HeNeCOn: An ontology for integrative research in Head and Neck cancer.

BACKGROUND: Head and Neck Cancer (HNC) has a high incidence and prevalence in the worldwide population. The broad terminology associated with these diseases and their multimodality treatments generates large amounts of heterogeneous clinical data, which motivates the construction of a high-quality harmonization model to standardize this multi-source clinical data in terms of format and semantics. The use of ontologies and semantic techniques is a well-known approach to face this challenge. OBJECTIVE: This work aims to provide a clinically reliable data model for HNC processes during all phases of the disease: prognosis, treatment, and follow-up. Therefore, we built the first ontology specifically focused on the HNC domain, named HeNeCOn (Head and Neck Cancer Ontology). METHODS: First, an annotated dataset was established to provide a formal reference description of HNC. Then, 170 clinical variables were organized into a taxonomy, and later expanded and mapped to formalize and integrate multiple databases into the HeNeCOn ontology. The outcomes of this iterative process were reviewed and validated by clinicians and statisticians. RESULTS: HeNeCOn is an ontology consisting of 502 classes, a taxonomy with a hierarchical structure, semantic definitions of 283 medical terms and detailed relations between them, which can be used as a tool for information extraction and knowledge management. CONCLUSION: HeNeCOn is a reusable, extendible and standardized ontology which establishes a reference data model for terminology structure and standard definitions in the Head and Neck Cancer domain. This ontology allows handling both current and newly generated knowledge in Head and Neck cancer research, by means of data linking and mapping with other public ontologies.

Innovation through the Quintuple Helix in living labs: lessons learned for a transformation from lab to ecosystem.

Introduction: In the process of growing societies, and especially in the digital era we live in, there is a need for a strong push for innovation that puts citizens at the center of the process from the beginning to build more resilient, cooperative and flexible communities. Different collaborative design approaches have emerged in recent decades, one of the most interesting being Living Labs, which involves user-centered design and co-creative innovation that bring together different actors and roles. However, although these new methodologies are harnessing creativity, some aspects of this new, more ecosystemic and complex vision are not clearly understood: possible barriers, how to facilitate local and operational solutions, overcoming institutional blockage, integrating new roles, etc. Methods: The incorporation of the Quintuple Helix as a driver to ensure greater coordinated participation of local actors has proven its usefulness and impact during the re-adaptation of LifeSpace (previously named Smart House Living Lab), managed by the Polytechnic University of Madrid (Spain), a transformation based on the experiences and lessons learned during the large-scale ACTIVAGE pilot funded by the European Commission, more specifically at the Madrid Deployment Site. It involved more than 350 older adult people and other stakeholders from different areas, including family members, formal and informal caregivers, hospital service managers, third-age associations, and public service providers, forming a sense of community, which was called MAHA. Results: The living lab infrastructure evolved from a single multi-purpose environment to incorporate three harmoniously competing environments: (1) THE LAB: Headquarters for planning, demonstration, initial design phases and entry point for newcomers to the process, (2) THE CLUB: Controlled interaction environment where returning users validate solutions, focusing mainly on AHA services (MAHA CLUB), such as exergames, social interaction applications, brain training activities, etc. (3) THE NEIGHBOURHOOD: Real-life environments for free and open interaction between actors and implementation of previously validated and tested solutions. Conclusion: The Quintuple Helix model applied in LifeSpace's new vision allows a coordinated involvement of a more diverse set of actors, beyond the end-users and especially those who are not traditionally part of research and innovation processes.

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.

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

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.

Promoting Obesity Prevention and Healthy Habits in Childhood: The OCARIoT Experience.

OBJECTIVE: Long term behavioural disturbances and interventions in healthy habits (mainly eating and physical activity) are the primary cause of childhood obesity. Current approaches for obesity prevention based on health information extraction lack the integration of multi-modal datasets and the provision of a dedicated Decision Support System (DSS) for health behaviour assessment and coaching of children. METHODS: Continuous co-creation process has been applied in the frame of the Design Thinking Methodology, involving children, educators and healthcare professional in the whole process. Such considerations were used to derive the user needs and the technical requirements needed for the conception of the Internet of Things (IoT) platform based on microservices. RESULTS: To promote the adoption of healthy habits and the prevention of the obesity onset for children (9-12 years old), the proposed solution empowers children -including families and educators- in taking control of their health by collecting and following-up real-time information about nutrition, physical activity data coming from IoT devices, and interconnecting healthcare professionals to provide a personalised coaching solution. The validation has two phases involving +400 children (control/intervention group), on four schools in three countries: Spain, Greece and Brazil. The prevalence of obesity decreased in 75.5% from baseline levels in the intervention group. The proposed solution created a positive impression and satisfaction from the technology acceptance perspective. CONCLUSIONS: Main findings confirm that this ecosystem can assess behaviours of children, motivating and guiding them towards achieving personal goals. Clinical and Translational Impact Statement-This study presents Early Research on the adoption of a smart childhood obesity caring solution adopting a multidisciplinary approach; it involves researchers from biomedical engineering, medicine, computer science, ethics and education. The solution has the potential to decrease the obesity rates in children aiming to impact to get a better global health.

Analysing associations between digitalization and the accomplishment of the Sustainable Development Goals.

Sustainability is a very complex concept made up of a multitude of interacting aspects that do not necessarily work synergistically with each other. The consequential outcome of cross-cutting drivers, such as digitalisation, is often difficult to assess, as the achievement of certain targets may also inadvertently hinder progress towards others. This investigation describes a comprehensive and systematic country-based analysis of statistical associations between digitalization and sustainability indicators operating at three different levels (i.e., index, goal and indicators). Results showed strong correlations between the composite indices for digitalization (IDI Development Index), sustainability (SDG Index from) and economic growth (GCI and GDP). However, the analysis of lower-level indicators provides a more ambiguous picture, with 2 of the sustainability goals and 22 % of the sustainability indicators included in the SDG Index showing negative associations with digitalisation. It appears that while synergies are generated in aspects related to economic and social sustainability, trade-offs occur in areas related to environmental protection such as climate change, depletion of natural resources and waste generation due to their negative associations with existing economic development models. These structural obstacles need to be acknowledged and adequately managed in order to ensuring harmonious and integral progress towards effective sustainability.

Psychosomatic response to acute emotional stress in healthy students.

The multidimensionality of the stress response has shown the complexity of this phenomenon and therefore the impossibility of finding a unique biomarker among the physiological variables related to stress. An experimental study was designed and performed to guarantee the correct synchronous and concurrent measure of psychometric tests, biochemical variables and physiological features related to acute emotional stress. The population studied corresponds to a group of 120 university students between 20 and 30 years of age, with healthy habits and without a diagnosis of chronic or psychiatric illnesses. Following the protocol of the experimental pilot, each participant reached a relaxing state and a stress state in two sessions of measurement for equivalent periods. Both states are correctly achieved evidenced by the psychometric test results and the biochemical variables. A Stress Reference Scale is proposed based on these two sets of variables. Then, aiming for a non-invasive and continuous approach, the Acute Stress Model correlated to the previous scale is also proposed, supported only by physiological signals. Preliminary results support the feasibility of measuring/quantifying the stress level. Although the results are limited to the population and stimulus type, the procedure and methodological analysis used for the assessment of acute stress in young people can be extrapolated to other populations and types of stress.

Definition and development of a digital system for the empowerment and activation of type 1 diabetic patient.

Health education is essential for type 1 diabetic patients to actively participate in the decision-making process about their disease. Under the framework of the INCAP project, a mobile application has been designed and developed with an easy-to-use interface for type 1 diabetic patients to improve their empowerment, activation and thus their self-control and improvement of their treatment adherence.

Data analytics for predicting quality of life changes in head and neck cancer survivors: a scoping review.

Head and neck cancer is the seventh most common cancer worldwide. The incidence of this cancer is increasing, but at the same time, the cancer-related mortality rate has decreased over time, leaving more head and neck cancer survivors. More emphasis is needed on quality-of-life research in the head and neck cancer field to improve their daily lives and reduce the disease and treatment response burden. To achieve this, we conducted a scoping review to find and learn which predictors and data analysis techniques have been used in previous studies. This work is undertaken in the context of the BD4QoL EU Research project.

Definition of a framework for the creation of a Living Labs network: the case of the European Living Labs and Test Beds Network focused on health care domain.

This paper describes the framework for the creation of a Living Labs network based on the experience of the setting up, growth and further consolidation of the European Living Labs and Test Beds Network focused on Health. The manuscript presents how to create an open innovation ecosystem through a network of Living Labs and Test Beds, introducing its value proposition and current status.

Design of a Training Model for Remote Management of Patients Hospitalized at Home.

PURPOSE: Hospitalization at Home (HaH) has proven to be more efficient and effective than conventional one, but it also requires a higher number of resources and specialised personnel. Information technologies can make this process scalable and allow physicians and nurses to deliver remote healthcare services for patients hospitalized at home. However, a correct and satisfactory usage of technology requires an adequate training of professionals and patients. This paper describes a new model for training healthcare professionals on managing remote ICT-based services for Hospitalization at Home. METHODS: The model was defined based on mix-method that combined the PICO model and a User Centred Design methodology, oriented to identify and discover the healthcare professionals needs and the training instruments in the literature that directly involved these professionals. These aspects were used in the definition and development of the assessment framework of the proposed training model. RESULTS: A training model for healthcare professionals focused on achieving an effective uptake of complex digital interventions such as Hospitalization at Home was defined. The selected mix-method led to the identification of four different blocks, that were considered as the main areas to include in a training programme. The model identifies measurable elements for assessing acceptability, workability increment and integration into daily clinical practice outcomes, as well as for evaluating the proposed training content and its outcomes. CONCLUSIONS: The proposed training model highlights the key aspects of training health professionals to favour an effective and successful implementation of complex technological healthcare interventions in the context of ICT-based HaH ICT.

User Centered Design to Improve Information Exchange in Diabetes Care Through eHealth : Results from a Small Scale Exploratory Study.

Heterogeneity of people with diabetes makes maintaining blood glucose control and achieving therapy adherence a challenge. It is fundamental that patients get actively involved in the management of the disease in their living environments. The objective of this paper is to evaluate the use and acceptance of a self-management system for diabetes developed with User Centered Design Principles in community settings. Persons with diabetes and health professionals were involved the design, development and evaluation of the self-management system; which comprised three iterative cycles: scenario definition, user archetype definition and system development. A comprehensive system was developed integrating modules for the management of blood glucose levels, medication, food intake habits, physical activity, diabetes education and messaging. The system was adapted for two types of principal users (personas): Type 1 Diabetes user and Type 2 Diabetes user. The system was evaluated by assessing the use, the compliance, the attractiveness and perceived usefulness in a multicenter randomized pilot study involving 20 patients and 24 treating professionals for a period of four weeks. Usage and compliance of the co-designed system was compared during the first and the last two weeks of the study, showing a significantly improved behaviour of patients towards the system for each of the modules. This resulted in a successful adoption by both type of personas. Only the medication module showed a significantly different use and compliance (p= 0.01) which can be explained by the different therapeutic course of the two types of diabetes. The involvement of patients to make their own decisions and choices form design stages was key for the adoption of a self-management system for diabetes.

What do healthcare professionals need to turn risk models for type 2 diabetes into usable computerized clinical decision support systems? Lessons learned from the MOSAIC project.

BACKGROUND: To understand user needs, system requirements and organizational conditions towards successful design and adoption of Clinical Decision Support Systems for Type 2 Diabetes (T2D) care built on top of computerized risk models. METHODS: The holistic and evidence-based CEHRES Roadmap, used to create eHealth solutions through participatory development approach, persuasive design techniques and business modelling, was adopted in the MOSAIC project to define the sequence of multidisciplinary methods organized in three phases, user needs, implementation and evaluation. The research was qualitative, the total number of participants was ninety, about five-seventeen involved in each round of experiment. RESULTS: Prediction models for the onset of T2D are built on clinical studies, while for T2D care are derived from healthcare registries. Accordingly, two set of DSSs were defined: the first, T2D Screening, introduces a novel routine; in the second case, T2D Care, DSSs can support managers at population level, and daily practitioners at individual level. In the user needs phase, T2D Screening and solution T2D Care at population level share similar priorities, as both deal with risk-stratification. End-users of T2D Screening and solution T2D Care at individual level prioritize easiness of use and satisfaction, while managers prefer the tools to be available every time and everywhere. In the implementation phase, three Use Cases were defined for T2D Screening, adapting the tool to different settings and granularity of information. Two Use Cases were defined around solutions T2D Care at population and T2D Care at individual, to be used in primary or secondary care. Suitable filtering options were equipped with "attractive" visual analytics to focus the attention of end-users on specific parameters and events. In the evaluation phase, good levels of user experience versus bad level of usability suggest that end-users of T2D Screening perceived the potential, but they are worried about complexity. Usability and user experience were above acceptable thresholds for T2D Care at population and T2D Care at individual. CONCLUSIONS: By using a holistic approach, we have been able to understand user needs, behaviours and interactions and give new insights in the definition of effective Decision Support Systems to deal with the complexity of T2D care.

Big data and machine learning in critical care: Opportunities for collaborative research.

The introduction of clinical information systems (CIS) in Intensive Care Units (ICUs) offers the possibility of storing a huge amount of machine-ready clinical data that can be used to improve patient outcomes and the allocation of resources, as well as suggest topics for randomized clinical trials. Clinicians, however, usually lack the necessary training for the analysis of large databases. In addition, there are issues referred to patient privacy and consent, and data quality. Multidisciplinary collaboration among clinicians, data engineers, machine-learning experts, statisticians, epidemiologists and other information scientists may overcome these problems. A multidisciplinary event (Critical Care Datathon) was held in Madrid (Spain) from 1 to 3 December 2017. Under the auspices of the Spanish Critical Care Society (SEMICYUC), the event was organized by the Massachusetts Institute of Technology (MIT) Critical Data Group (Cambridge, MA, USA), the Innovation Unit and Critical Care Department of San Carlos Clinic Hospital, and the Life Supporting Technologies group of Madrid Polytechnic University. After presentations referred to big data in the critical care environment, clinicians, data scientists and other health data science enthusiasts and lawyers worked in collaboration using an anonymized database (MIMIC III). Eight groups were formed to answer different clinical research questions elaborated prior to the meeting. The event produced analyses for the questions posed and outlined several future clinical research opportunities. Foundations were laid to enable future use of ICU databases in Spain, and a timeline was established for future meetings, as an example of how big data analysis tools have tremendous potential in our field.

Silver Nanoparticles and Polyphenol Inclusion Compounds Composites for Phytophthora cinnamomi Mycelial Growth Inhibition.

Phytophthora cinnamomi, responsible for "root rot" or "dieback" plant disease, causes a significant amount of economic and environmental impact. In this work, the fungicide action of nanocomposites based on silver nanoparticles and polyphenol inclusion compounds, which feature enhanced bioavailability and water solubility, was assayed for the control of this soil-borne water mold. Inclusion compounds were prepared by an aqueous two-phase system separation method through extraction, either in an hydroalcoholic solution with chitosan oligomers (COS) or in a choline chloride:urea:glycerol deep eutectic solvent (DES). The new inclusion compounds were synthesized from stevioside and various polyphenols (gallic acid, silymarin, ferulic acid and curcumin), in a [6:1] ratio in the COS medium and in a [3:1] ratio in the DES medium, respectively. Their in vitro response against Phytophthora cinnamomi isolate MYC43 (at concentrations of 125, 250 and 500 µg·mL-1) was tested, which found a significant mycelial growth inhibition, particularly high for the composites prepared using DES. Therefore, these nanocomposites hold promise as an alternative to fosetyl-Al and metalaxyl conventional systemic fungicides.

A dashboard-based system for supporting diabetes care.

Objective: To describe the development, as part of the European Union MOSAIC (Models and Simulation Techniques for Discovering Diabetes Influence Factors) project, of a dashboard-based system for the management of type 2 diabetes and assess its impact on clinical practice. Methods: The MOSAIC dashboard system is based on predictive modeling, longitudinal data analytics, and the reuse and integration of data from hospitals and public health repositories. Data are merged into an i2b2 data warehouse, which feeds a set of advanced temporal analytic models, including temporal abstractions, care-flow mining, drug exposure pattern detection, and risk-prediction models for type 2 diabetes complications. The dashboard has 2 components, designed for (1) clinical decision support during follow-up consultations and (2) outcome assessment on populations of interest. To assess the impact of the clinical decision support component, a pre-post study was conducted considering visit duration, number of screening examinations, and lifestyle interventions. A pilot sample of 700 Italian patients was investigated. Judgments on the outcome assessment component were obtained via focus groups with clinicians and health care managers. Results: The use of the decision support component in clinical activities produced a reduction in visit duration (P ≪ .01) and an increase in the number of screening exams for complications (P < .01). We also observed a relevant, although nonstatistically significant, increase in the proportion of patients receiving lifestyle interventions (from 69% to 77%). Regarding the outcome assessment component, focus groups highlighted the system's capability of identifying and understanding the characteristics of patient subgroups treated at the center. Conclusion: Our study demonstrates that decision support tools based on the integration of multiple-source data and visual and predictive analytics do improve the management of a chronic disease such as type 2 diabetes by enacting a successful implementation of the learning health care system cycle.

Integration of Personalized Healthcare Pathways in an ICT Platform for Diabetes Managements: A Small-Scale Exploratory Study.

The availability of new tools able to support patient monitoring and personalized care may substantially improve the quality of chronic disease management. A personalized healthcare pathway (PHP) has been developed for diabetes disease management and integrated into an information and communication technology system to accomplish a shift from organization-centered care to patient-centered care. A small-scale exploratory study was conducted to test the platform. Preliminary results are presented that shed light on how the PHP influences system usage and performance outcomes.

Parsimonious Description of Glucose Variability in Type 2 Diabetes by Sparse Principal Component Analysis.

BACKGROUND: Abnormal glucose variability (GV) is a risk factor for diabetes complications, and tens of indices for its quantification from continuous glucose monitoring (CGM) time series have been proposed. However, the information carried by these indices is redundant, and a parsimonious description of GV can be obtained through sparse principal component analysis (SPCA). We have recently shown that a set of 10 metrics selected by SPCA is able to describe more than 60% of the variance of 25 GV indicators in type 1 diabetes (T1D). Here, we want to extend the application of SPCA to type 2 diabetes (T2D). METHODS: A data set of CGM time series collected in 13 T2D subjects was considered. The 25 GV indices considered for T1D were evaluated. SPCA was used to select a subset of indices able to describe the majority of the original variance. RESULTS: A subset of 10 indicators was selected and allowed to describe 83% of the variance of the original pool of 25 indices. Four metrics sufficient to describe 67% of the original variance turned out to be shared by the parsimonious sets of indices in T1D and T2D. CONCLUSIONS: Starting from a pool of 25 indices assessed from CGM time series in T2D subjects, reduced subsets of metrics virtually providing the same information content can be determined by SPCA. The fact that these indices also appear in the parsimonious description of GV in T1D may indicate that they could be particularly informative of GV in diabetes, regardless of the specific type of disease.

Automatic messaging for improving patients engagement in diabetes management: an exploratory study.

Mobile health systems aiming to promote adherence may cost-effectively improve the self-management of chronic diseases like diabetes, enhancing the compliance to the medical prescription, encouraging and stimulating patients to adopt healthy life styles and promoting empowerment. This paper presents a strategy for m-health applications in diabetes self-management that is based on automatic generation of feedback messages. A feedback assistant, representing the core of architecture, delivers dynamic and automatically updated text messages set up on clinical guideline and patient's lifestyle. Based on this strategy, an m-health adherence system was designed, developed and tested in a small-scale exploratory study with T1DM and T2DM patients. The results indicate that the system could be feasible and well accepted and that its usage increased along with adherence to prescriptions during the 4 weeks of the study. A more extensive research is pending to corroborate these outcomes and to establish a clear benefit of the proposed solution.

Use of an holistic approach for effective adoption of User-Centred-Design techniques in diabetes disease management: Experiences in user need elicitation.

One of the most important challenges of designing eHealth tools for Chronic Disease Management is to understand how transforming cutting-edge innovations in something that can impact the current clinical practice and improve the performance of the health care systems. The adoption of User Centered Design techniques is fundamental in order to integrate these systems in an effective and successful way. The work presented in this paper describe the methodologies used in the context of two multidisciplinary research projects, METABO and MOSAIC. The adoption of the methodologies have been driven by the CeHRes Roamap, a holistic framework that support participatory development of eHealth. The work reported in this paper describes the results of the first two (out of the five) phases in eliciting user needs.