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Background: Patients with melanoma receiving immunotherapy with immune-checkpoint inhibitors often experience immune-related adverse events, cancer-related fatigue, and emotional distress, affecting health-related quality of life (HRQoL) and clinical outcome to immunotherapy. eHealth tools can aid patients with cancer in addressing issues, such as adverse events and psychosocial well-being, from various perspectives., Objective: This study aimed to explore the effect of the Cancer Patients Better Life Experience (CAPABLE) system, accessed through a mobile app, on HRQoL compared with a matched historical control group receiving standard care. CAPABLE is an extensively tested eHealth app, including educational material, remote symptom monitoring, and well-being interventions., Methods: This prospective pilot study compared an exploratory cohort that received the CAPABLE smartphone app and a multisensory smartwatch for 6 months (intervention) to a 2:1 individually matched historical prospective control group. HRQoL data were measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 at baseline (T0), 3 months (T1), and 6 months (T2) after start of treatment. Mixed effects linear regression models were used to compare HRQoL between the 2 groups over time., Results: From the 59 eligible patients for the CAPABLE intervention, 31 (53%) signed informed consent to participate. Baseline HRQoL was on average 10 points higher in the intervention group compared with controls, although equally matched on baseline and clinical characteristics. When correcting for sex, age, disease stage, and baseline scores, an adjusted difference in fatigue of -5.09 (95% CI -15.20 to 5.02, P=.32) at month 3 was found. No significant nor clinically relevant adjusted differences on other HRQoL domains over time were found. However, information satisfaction was significantly higher in the CAPABLE group (β=8.71, 95% CI 1.54-15.88, P=.02)., Conclusions: The intervention showed a limited effect on HRQoL, although there was a small improvement in fatigue at 3 months, as well as information satisfaction. When aiming at personalized patient and survivorship care, further optimization and prospective investigation of eHealth tools is warranted., (© Itske Fraterman, Lucia Sacchi, Henk Mallo, Valentina Tibollo, Savannah Lucia Catherina Glaser, Stephanie Medlock, Ronald Cornet, Matteo Gabetta, Vitali Hisko, Vadzim Khadakou, Ella Barkan, Laura Del Campo, David Glasspool, Alexandra Kogan, Giordano Lanzola, Roy Leizer, Manuel Ottaviano, Mor Peleg, Konrad Śniatała, Aneta Lisowska, Szymon Wilk, Enea Parimbelli, Silvana Quaglini, Mimma Rizzo, Laura Deborah Locati, Annelies Boekhout, Lonneke V van de Poll-Franse, Sofie Wilgenhof. Originally published in JMIR Cancer (https://cancer.jmir.org).)

Background: Within the CAPABLE project the authors developed a multi-agent system that relies on a distributed architecture. The system provides cancer patients with coaching advice and supports their clinicians with suitable decisions based on clinical guidelines., Objectives: As in many multi-agent systems we needed to coordinate the activities of all agents involved. Moreover, since the agents share a common blackboard where all patients' data are stored, we also needed to implement a mechanism for the prompt notification of each agent upon addition of new information potentially triggering its activation., Methods: The communication needs have been investigated and modeled using the HL7-FHIR (Health Level 7-Fast Healthcare Interoperability Resources) standard to ensure proper semantic interoperability among agents. Then a syntax rooted in the FHIR search framework has been defined for representing the conditions to be monitored on the system blackboard for activating each agent., Results: The Case Manager (CM) has been implemented as a dedicated component playing the role of an orchestrator directing the behavior of all agents involved. Agents dynamically inform the CM about the conditions to be monitored on the blackboard, using the syntax we developed. The CM then notifies each agent whenever any condition of interest occurs. The functionalities of the CM and other actors have been validated using simulated scenarios mimicking the ones that will be faced during pilot studies and in production., Conclusion: The CM proved to be a key facilitator for properly achieving the required behavior of our multi-agent system. The proposed architecture may also be leveraged in many clinical contexts for integrating separate legacy services, turning them into a consistent telemedicine framework and enabling application reusability., Competing Interests: D.G. is an employee of and shareholder in Deontics Ltd., which is the company producing the PROforma CIG authoring tool and the execution engine. The remaining authors have no conflict of interest of any kind to declare., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Patient reported outcomes have been shown to be predictive of cancer patients' prognosis, and their monitoring through electronic applications have been shown to positively impact survival. On the other hand, patient apps in general show a number of criticalities that often lead patients to abandon their use. One of them is usability. A scarce attention to usability during app development leads to unsatisfactory user experience. In this work, we present an algorithm to facilitate patient symptoms reporting, by personalising the list of symptoms according to their probability of occurrence in the specific patient. This avoids searching long lists of items, thus decreasing the patients' burden in symptom reporting.

The CAPABLE project has been funded by the EU Horizon 2020 Programme over the years 2020-24 to support home care. A system is being designed and implemented supporting remote monitoring and virtual coaching for cancer patients. The system is based on a distributed modular architecture involving many components encapsulating various knowledge. The Case Manager has been designed as a separate component with the aim of coordinating the problem solving strategies. A first version of the Case Manager has been released and used by the components in a prototypical scenario shown at the first project review.

Poor patient compliance to therapy results in a worsening condition that often increases healthcare costs. In the MobiGuide project, we developed an evidence-based clinical decision-support system that delivered personalized reminders and recommendations to patients, helping to achieve higher therapy compliance. Yet compliance could still be improved and therefore building on the MobiGuide project experience, we designed a new component called the Motivational Patient Assistant (MPA) that is integrated within the MobiGuide architecture to further improve compliance. This component draws from psychological theories to provide behavioral support to improve patient engagement and thereby increasing patients' compliance. Behavior modification interventions are delivered via mobile technology at patients' home environments. Our approach was inspired by the IDEAS (Integrate, Design, Assess, and Share) framework for developing effective digital interventions to change health behavior; it goes beyond this approach by extending the Ideation phase' concepts into concrete backend architectural components and graphical user-interface designs that implement behavioral interventions. We describe in detail our ideation approach and how it was applied to design the user interface of MPA for anticoagulation therapy for the atrial fibrillation patients. We report results of a preliminary evaluation involving patients and care providers that shows the potential usefulness of the MPA for improving compliance to anticoagulation therapy.

Introduction In the past years, we developed a telemonitoring service for young patients affected by Type 1 Diabetes. The service provides data to the clinical staff and offers an important tool to the parents, that are able to oversee in real time their children. The aim of this work was to analyze the parents' perceived usefulness of the service. Methods The service was tested by the parents of 31 children enrolled in a seven-day clinical trial during a summer camp. To study the parents' perception we proposed and analyzed two questionnaires. A baseline questionnaire focused on the daily management and implications of their children's diabetes, while a post-study one measured the perceived benefits of telemonitoring. Questionnaires also included free text comment spaces. Results Analysis of the baseline questionnaires underlined the parents' suffering and fatigue: 51% of total responses showed a negative tendency and the mean value of the perceived quality of life was 64.13 in a 0-100 scale. In the post-study questionnaires about half of the parents believed in a possible improvement adopting telemonitoring. Moreover, the foreseen improvement in quality of life was significant, increasing from 64.13 to 78.39 ( p-value = 0.0001). The analysis of free text comments highlighted an improvement in mood, and parents' commitment was also proved by their willingness to pay for the service (median = 200 euro/year). Discussion A high number of parents appreciated the telemonitoring service and were confident that it could improve communication with physicians as well as the family's own peace of mind.

Objectives: The main purpose of the article is to raise awareness among all the involved stakeholders about the risks and legal implications connected to the development and use of modern telemedicine systems. Particular focus is given to the class of "active" telemedicine systems, that imply a real-world, non-mediated, interaction with the final user. A secondary objective is to give an overview of the European legal framework that applies to these systems, in the effort to avoid defensive medicine practices and fears, which might be a barrier to their broader adoption., Methods: We leverage on the experience gained during two international telemedicine projects, namely MobiGuide (pilot studies conducted in Spain and Italy) and AP@home (clinical trials enrolled patients in Italy, France, the Netherlands, United Kingdom, Austria and Germany), whose development our group has significantly contributed to in the last 4 years, to create a map of the potential criticalities of active telemedicine systems and comment upon the legal framework that applies to them. Two workshops have been organized in December 2015 and March 2016 where the topic has been discussed in round tables with system developers, researchers, physicians, nurses, legal experts, healthcare economists and administrators., Results: We identified 8 features that generate relevant risks from our example use cases. These features generalize to a broad set of telemedicine applications, and suggest insights on possible risk mitigation strategies. We also discuss the relevant European legal framework that regulate this class of systems, providing pointers to specific norms and highlighting possible liability profiles for involved stakeholders., Conclusions: Patients are more and more willing to adopt telemedicine systems to improve home care and day-by-day self-management. An essential step towards a broader adoption of these systems consists in increasing their compliance with existing regulations and better defining responsibilities for all the involved stakeholders., (Copyright © 2018 Elsevier B.V. All rights reserved.)

An increasing prevalence of chronic diseases is observed, among which cancer is now included because of its survival rates. That trend requires new ways of supporting outpatients and improving their compliance to treatments. This paper introduces HeNeA, a mobile application designed to support patients affected by Head and Neck cancer during their treatments. The application leverages on the mHealth features described in the literature and has been reviewed by a small set of patients during its development. Further evaluation is expected to occur when it will be offered to every eligible patient discharged from the Head and Neck division of a major Italian cancer centre.

Background: The use of surveys is becoming popular in the health care industry for acquiring information useful to the accomplishment of several studies. Besides their exploitation on a large scale for conducting epidemiological studies, surveys are being increasingly carried out on a narrower perspective through the administration of questionnaires aimed at assessing the quality of life perceived by patients or their clinical status during mid- or long-term treatments. This is useful for managing resources or optimizing and individualizing treatments., Objectives: This paper describes Gquest, a platform for modeling, generating and administering questionnaires through mobile devices such as smartphones or tablets. Gquest was motivated by the need of administering questionnaires during home treatments, albeit its applicability is rather general. The main requirement was to have a very simple, clean and easy to use platform able to support (a) physicians in the design and delivery of questionnaires and (b) outpatients in sending self-recorded outcomes to the clinical staff., Methods: Gquest has two basic components. The first one is a model devised for representing questionnaires which is extremely flexible. It allows the generation of questions and answers of different types, supports adaptivity in the dialog with the user and enforces simple consistency rules for checking his input. The second component is an application able to run instances of those questionnaires. It downloads questionnaires over the air in terms of XML files from a server and stores them locally into the mobile repository. Questionnaires become then available to the user, who in our case is a patient or one of his relatives. The user can select which one to fill-in, according to his needs and/or the specific treatment protocol. The selected questionnaire may be filled-in all at once or be completed in subsequent steps over time since any input provided is persisted on a local database. Finally, when a questionnaire is closed all the answers are transparently synchronized to a server for further evaluation or statistical purposes., Results: The platform has been exploited and tested in two medical domains where questionnaires have very different purposes; a quality of life pilot survey involving patients with atrial fibrillation within the EU-funded project MobiGuide, and an investigation of the users' needs during the requirements elicitation phase of a telemedicine project for the safe discharge of fragile patients., Conclusions: Gquest proved to be a suitable tool for dealing with a wide variety of question types and has been positively accepted by the patients enrolled in the pilot study., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Purpose: Effective communication between patients and health services providers is a key aspect for optimizing and maintaining these services. This work describes a system for the automatic evaluation of users' perception of the quality of SmsCup, a reminder system for outpatient visits based on short message service (SMS). The final purpose is the creation of a closed-loop control system for the outpatient service, where patients' complaints and comments represent a feedback that can be used for a better implementation of the service itself., Methods: SmsCup was adopted since about eight years by an Italian healthcare organization, with very good results in reducing the no-show (missing visits) phenomenon. During these years, a number of citizens, even if not required, sent a message back, with comments about the service. The automatic interpretation of the content of those SMS may be useful for monitoring and improving service performances.Yet, due to the complex nature of SMS language, their interpretation represents an ongoing challenge. The proposed system uses conditional random fields as the information extraction method for classifying messages into several semantic categories. The categories refer to appreciation of the service or complaints of various types. Then, the system analyzes the extracted content and provides feedback to the service providers, making them learning and acting on this basis., Results: At each step, the content of the messages reveals the actual state of the service as well as the efficacy of corrective actions previously undertaken. Our evaluations showed that: (i) the SMS classification system has achieved good overall performance with an average F1-measure and an overall accuracy of about 92%; (ii) the notification of the patients' feedbacks to service providers showed a positive impact on service functioning., Conclusions: Our study proposed an interactive patient-centered system for continuous monitoring of the service quality. It has demonstrated the feasibility of a tool for the analysis and notification of the patients' feedback on their service experiences, which would support a more regular access to the service., (Copyright © 2014 Elsevier Inc. All rights reserved.)

We illustrate G-quest, a platform originally meant to deliver questionnaires on mobile devices that supports the accomplishment of studies involving outpatients. However the constructs made available by the platform proved to be useful also for distributing learning material and checklists, after a paradigm shift in their application was adopted. Thus, in addition to questionnaires, we designed a guide for educating patients affected by a rare disease and conducted a small survey to assess this new application context. Presently we are exploiting G-quest for the provision of medical checklists in critical care.

This work evaluates the users' satisfaction with an SMS-based reminder system that is being used since about six years by an Italian healthcare organization. The system was implemented for reducing dropouts. This goal has been achieved, as dropout decreased from 8% to 4%. During these years, a number of reminded citizens, even not required, sent an SMS message back, with comments about the service, further requirements, etc. We collected some thousands of them. Their analysis may represent a useful feedback to the healthcare organization. We used conditional random fields as the information extraction method for classifying messages into appreciation, critique, inappropriateness, etc. The classification system achieved a very good overall performance (F1-measure of 94%), thus it can be used from here on to monitor the users' satisfaction in time.

Recent studies suggest that the quality of recovery after a stroke can be increased by early and more intensive rehabilitation. Portable unobtrusive devices are promising candidates for the realization of stroke-rehabilitation systems that complement care in the post-acute rehabilitation phase, both in the clinic and at home. The proposed system allows patients to increase the amount of motor exercise they can perform in autonomy, providing them with a real-time feedback based on wearable sensors embedded in the garment's tissue across the upper limb and trunk. A dynamic time warping algorithm allows for the recognition of correct and incorrect motor exercises. After the feedback phase, data are stored in a central location for review and statistics. Workstations can be installed either at home or at the hospital to support patients, independent of their location. The performance of the system on healthy subjects was quantified for seven types of motor exercises for upper limb's rehabilitation. Finally, we present the preliminary results of a pilot clinical study to test the system's acceptability and usability by post-stroke patients, and physicians in a clinical setting.

The management of chronic and out-patients is a complex process which requires the cooperation of different agents belonging to several organizational units. Patients have to move to different locations to access the necessary services and to communicate their health status data. From their point of view there should be only one organization (Virtual Health-Care Organization) which provides both virtual and face-to-face encounters. In this paper we propose the Serviceflow Management System as a solution to handle these information and the communication requirements. The system consists of: (a) the model of the care process represented as a Serviceflow and developed using the Workflow Management System YAWL; (b) an organizational ontology representing the VHCO; and (c) agreements and commitments between the parties defined in a contract (represented as an XML document). On the basis of a general architecture we present an implementation in the area of Diabetes management.

Stroke is a serious neurological accident which accounts for a wide fraction of the healthcare costs in industrialized societies. Recovery from stroke and other neurological accidents usually include motor rehabilitation, maintained for several months, and logopedic training for the recovery of cognitive and speech abilities. The MyHeart consortium is addressing several aspects of cardiovascular diseases' management by combining clothes with embedded biomedical sensors and information technologies. One of the application areas is especially devoted to supporting Neurological Rehabilitation (NR). This article describes how MyHeart's Concept NR is structured and how technologies are leveraged to support both motor rehabilitation and speech/cognitive training. Information technology and garment-embedded sensors, combined, permit assisted training both at the clinic and at home, after discharge from the intensive care unit.

We describe a telemedicine application for emergency management in Stroke Units, where prompt decisions must be taken, often knowing neither the clinical history nor the stroke symptoms onset modality. We have designed and implemented an Information and Communication Technology architecture for the situation in which a general practitioner is called for a suspected stroke and provides for the admission to a Stroke Unit. By means of a palmtop and a wireless Internet connection, he can send to the Stroke Unit the demographic data, the list of the patient's problems, current and/or recent therapies, and a guideline-based stroke-specific form with the objective examination results. In this way, the Stroke Unit team is alerted and informed before the patient arrival, and can manage the urgency at the best. The proposal involved 20 general practitioners and one Stroke Unit in the Lombardia Region, Italy.