An adaptive case management system to support integrated care services: Lessons learned from the NEXES project.

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An adaptive case management system to support integrated care services: Lessons learned from the NEXES project Isaac Cano a,⇑, Albert Alonso a, Carme Hernandez a, Felip Burgos a, Anael Barberan-Garcia a, Jim Roldan b, Josep Roca a a b

Hospital Clínic, IDIBAPS, CIBERES, Universitat de Barcelona, C/Villarroel 170, 08036 Barcelona, Spain Linkcare Health Services, C/Roger de Llúria 50, Sobreático A, 08009 Barcelona, Spain

a r t i c l e

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Article history: Received 10 November 2014 Revised 23 February 2015 Accepted 28 February 2015 Available online xxxx Keywords: Adaptive case management Integrated health care systems Medical internet of things Coordinated care Personalized care

a b s t r a c t Background: Extensive deployment and sustainability of integrated care services (ICS) constitute an unmet need to reduce the burden of chronic conditions. The European Union project NEXES (2008– 2013) assessed the deployment of four ICS encompassing the spectrum of severity of chronic patients. Objective: The current study aims to (i) describe the open source Adaptive Case Management (ACM) system (LinkcareÒ) developed to support the deployment of ICS at the level of healthcare district; (ii) to evaluate its performance; and, (iii) to identify key challenges for regional deployment of ICS. Methods: We first defined a conceptual model for ICS management and execution composed of five main stages. We then specified an associated logical model considering the dynamic runtime of ACM. Finally, we implemented the four ICS as a physical model with an ICS editor to allow professionals (case managers) to play active roles in adapting the system to their needs. Instances of ICS were then run in LinkcareÒ. Four ICS provided a framework for evaluating the system: Wellness and Rehabilitation (W&R) (number of patients enrolled in the study (n) = 173); Enhanced Care (EC) in frail chronic patients to prevent hospital admissions, (n = 848); Home Hospitalization and Early Discharge (HH/ED) (n = 2314); and, Support to remote diagnosis (Support) (n = 7793). The method for assessment of telemedicine applications (MAST) was used for iterative evaluation. Results: LinkcareÒ supports ACM with shared-care plans across healthcare tiers and offers integration with provider-specific electronic health records. LinkcareÒ successfully contributed to the deployment of the four ICS: W&R facilitated long-term sustainability of training effects (p < 0.01) and active life style (p < 0.03); EC showed significant positive outcomes (p < 0.05); HH/ED reduced on average 5 in-hospital days per patient with a 30-d re-admission rate of 10%; and, Support, enhanced community-based quality forced spirometry testing (p < 0.01). Key challenges for regional deployment of personalized care were identified. Conclusions: LinkcareÒ provided the required functionalities to support integrated care adopting an ACM model, and it showed adaptive potential for its implementation in different health scenarios. The research generated strategies that contributed to face the challenges of the transition toward personalized medicine for chronic patients. Ó 2015 Elsevier Inc. All rights reserved.

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1. Introduction

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Health systems worldwide are facing a profound evolution driven by three major forces that are converging in terms of their impact on health information systems. Firstly, the epidemics of non-communicable diseases [1–3] is prompting both conceptual

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⇑ Corresponding author at: IDIBAPS Research Institute, C/Villarroel 170, 08036 Barcelona, Spain. Tel.: +34 932 275 747; fax: +34 932 275 455. E-mail address: [email protected] (I. Cano).

and organizational changes in the way we approach the delivery of care for chronic patients. A second vector of change is the need to ensure financial sustainability of healthcare systems by generating efficiencies that ideally should lead to containment of overall healthcare costs without precluding the necessary innovations [1]. Last, but not least, Systems Medicine [4] is proposing an innovative approach to our understanding of disease mechanisms that is contributing to build-up personalized medicine [5] with important implications on future strategies for personalized chronic patient management.

http://dx.doi.org/10.1016/j.jbi.2015.02.011 1532-0464/Ó 2015 Elsevier Inc. All rights reserved.

Please cite this article in press as: Cano I et al. An adaptive case management system to support integrated care services: Lessons learned from the NEXES project. J Biomed Inform (2015), http://dx.doi.org/10.1016/j.jbi.2015.02.011

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Nomenculture Abbrevations ACM adaptive case management ACMS adaptive case management system BPMN business process modelling notation CDSS clinical decision support systems CMMN case management model and notation EAI enterprise application integration EHR electronic health record

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A commonality of these three driving forces is the need for efficient and intensive use of Information and Communication Technologies (ICT) to support novel Integrated Care Services (ICS) for chronic patients [6]. However, conventional Health Information Systems (HIS) only very rarely incorporate the required process logic to support ICS management [7]. Conventional care relies on the management of clinical episodes with a disease-oriented approach, whereas in ICS continuity of care with a patient-centered approach are the key principles. Most importantly, integrated care requires cooperation among healthcare providers, across healthcare tiers, and with social support. We acknowledge that examples of successfully addressing the technological requirements associated with the deployment of ICS within a given health information network do exist [8,9]. However, this issue remains a major challenge in those healthcare sectors with heterogeneous providers each one using proprietary HIS. Moreover, there is a need for new paradigms bridging traditional Electronic Heath Records (EHR) and informal care through patient’s personal health records. The current study describes an open source ICT platform (LinkcareÒ) developed to support the process logics of integrated care. To this end, a family of four ICS evaluated in the European project NEXES [10] and deployed in Barcelona provided a framework for evaluating the system. NEXES aimed at assessing the deployment of the four different but articulated ICS covering most of the spectrum of severity of chronic patients. The project was conducted in three European sites: Barcelona (Catalonia); Trondheim (Norway) and Athens (Greece) following similar clinical protocols, but different organizational approaches and diverse ICT support. The hypothesis behind the study was that the transfer of service complexities from hospital-based specialized care to community care could enhance health outcomes while containing overall costs at health system level. Therefore, the central challenge was for the LinkcareÒ ICT platform to support the process logic of ICS that allow case management with an integrated care approach. The current manuscript describes the steps followed to develop the logics of the clinical processes (i.e. case identification, case evaluation, work plan definition, follow-up and event handling, and discharge) and the associated ICT support. It also reports on the four ICS in which LinkcareÒ was tested and on the healthcare outcomes generated by the project in Barcelona. Finally, we present the lessons learned in NEXES that should be useful for regional deployment of integrated care, as well as to foster future personalized care for chronic patients.

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2. Materials and methods

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The initial logic models for case management with an integrated care approach were build-up based on the Business Process Model and Notation (BPMN) [11] formalism, but two main

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EU HIE HIS ICS ICP ICT SOAP

European Union Health Information Exchange health information system integrated care service integrated care protocol information and communication technologies simple object access protocol

limitations were identified; that is, lack of contextualization and poor dynamic adaptation to changes. Ad-hoc modifications to BPMN implemented in the process of development of the ICT platform fit with the Adaptive Case Management (ACM) model [12], reported at the end of the decade, that was later formalized as the Case Management Model and Notation (CMMN v1.0) specification [13]. Consequently, further developments in the LinkcareÒ platform have followed an ACM approach, as described in the manuscript.

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2.1. Adaptive case management

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In NEXES, Integrated Care Services (ICS) are defined as a set of well-standardized tasks to be carried out to a patient on the basis of his/her health condition and social circumstances to achieve target objectives, aligned with the comprehensive treatment plan. Two differential characteristics of the approach, as compared to usual care, are: (i) its patient centeredness; and, (ii) the longitudinal nature of the interventions which duration depends on the type of Integrated Care Service. One patient can be assigned to one or more integrated care services within a given time frame depending upon his/her individual needs. Having the above definition of ICS into account, the ACM model was considered to build-up the process logic of each ICS because ACM provides the infrastructure for knowledge-based work (e.g. case management) that conventional systems cannot support

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Fig. 1. Conceptual stages of Integrated Care Services (ICS) considered in this study.


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having a role in ICS management and execution. ICP templates are composed of admission and discharge form templates and a customizable work plan, which is used as the reference guide for task scheduling and for the generation of follow-up reports. Finally, event handling is provided during the execution of the personalized work plan.

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because processes are too dynamic, variable and unstructured. The overarching goal of the ACM approach is to enable the case manager to face new cases reusing structured experiences with previous cases without needing any special skills. Over time, the case manager should be able to adapt the system to his or her own style of working without needing the help of any specialist.

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2.2. A conceptual model for ICS

2.4. A physical model for ICS

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Fig. 1 shows a variety of stages in ICS adaptive case management: (i) case identification; (ii) case evaluation, (iii) work plan definition; (iv) follow-up event handling; and, (v) ICS discharge or exitus. Case identification refers to the patient’s information required at the entry point. Case evaluation includes assessment of the patient to determine his/her eligibility for the ICS and to capture the information required for the next step, work plan definition. The work plan consists on a set of both timed and nontimed tasks, led by a team of healthcare professionals or the patient itself, aligned with the aims of the ICS for that specific case. Follow-up and event handling, corresponds to the execution of the working plan. It is of note, that the continuous patient’s assessment during this phase may lead to changes in the working plan triggered by unexpected events. Finally, the case is prepared for his/ her discharge from the ICS.

The design of the ACM system considered in this study use an ICS editor to implement physically the logical model for ICS that runs in LinkcareÒ. In summary, the ICS editor is a suite of tools to manage graphically the following main ICS components:

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– LinkcareÒ users this interface allows managing user roles (e.g. patient/Caregiver, health & social care professional, assistant, system administration, etc.) participating in any ICS. – Integrated care protocol templates ICP templates serve as a reference work plan being later customized to patient-specific conditions and the local characteristics of the healthcare provider. – ICS tasks the reference work plan is composed of a set of tasks or interventions (e.g. questionnaires and checklists (see examples in Appendix B), vendor-specific remote monitoring of vital signs, audio and video conferences, etc.) scheduled to be executed during a predefined period of time, or always available (patient’s optional tasks).

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2.3. A logical model for ICS

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Each of the sequential building blocks of a given ICS (Fig. 1) typically involves the participation of a limited number of actors. If properly designed, each of these blocks should render outcomes that are relevant for execution of the next phase. Identification of tasks and allocation of them to the different actors was initially described in NEXES using the BPMN [11] formalism. Specifically, BPMN was used to create the process logic of the ICS care plans for individual patients and to formalize the core functional requirements of LinkcareÒ. This is to be complemented by other non-functional requirements, including interoperability with existing proprietary Health Information Systems (HIS) and privacy and security controls. However, Adaptive Case Management (ACM) [12] in the context of ICS involves enhanced contextualization of actions and flexible execution of activities that depend on evolving circumstances and ad hoc decisions. To this end, the internal relational entities illustrated in Fig. 2 were considered. The ICS Library contains the set of available Integrated Care Protocol (ICP) templates and the system users potentially

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2.5. System development and assessment

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LinkcareÒ was developed using Enterprise Application Integration (EAI) software architectural principles [14] since they provide a common basic set of ICT solutions for integration at site level with potential for scalability. This option allowed integration with external legacy systems using interoperability middlewares for extending the core module with third-party functionalities. The European legislation on health data transfer and security [15–18], as well as the specifics of its real application at site level were analyzed and compared with particular emphasis on the impact of ICSs deployment. Moreover, the international regulations on medical devices [19–21] were also considered in the design of LinkcareÒ. Crucial to the success in adopting the proposed ICT solution was the goodness of fit between technology and work practices of the end users [22]. To this end, at different time points in the process of implementing the current version of LinkcareÒ, different

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Fig. 2. LinkcareÒ relational entities to support Adaptive Case Management (ACM) in the context of ICS.


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evaluation methods and tools were applied with specific purposes following the iterative approach described by Catwell and Sheikh [22]. Since early development phases, we introduced specific tools of formative evaluation to verify assumptions, generate understanding and reveal incidences in order to minimize future problems, namely: misunderstanding of specifications, rejections by end-users, etc. To this end, the Method for the ASsessment of Telemedicine applications (MAST) [23] was used for iteratively evaluating the technological developments supporting the field studies (Section 2.6). While we have kept the MAST model as a reference for the assessment of the field studies, we have introduced some adaptations to the specificities of the services and applications, as required by the field studies. The following domains or dimensions (D) of the MAST model were covered: D1: clinical and technical safety, D2: clinical effectiveness, D3: user perspectives, D4: economic aspects, D5: organizational aspects D6: social, legal and ethical aspects and D7: transferability. The seven dimensions (D1-D7) considered for the assessment of the field studies are described in detail in Appendix A.1. Moreover, when LinkcareÒ was operational, we incorporated tools of summative evaluation to assess outputs.

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2.6. Field studies

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The NEXES project targeted chronic patients with obstructive pulmonary disease (COPD), cardiac failure and/or type II diabetes mellitus. Main characteristics of the study design for the field studies conducted to assess the four ICS in which LinkcareÒ was tested are summarized below and the description is expanded in the online supplementary material (Appendix A) wherein the BPMN design of each ICS can be found.

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2.6.3. Home hospitalization and Early Discharge The service provided an acute, home-based, short-term intervention aiming at fully (Home Hospitalization) or partially (Early Discharge) substituting conventional hospitalization. Home Hospitalization/Early Discharge was delivered by trained hospital personnel for a period of time that is usually not longer than the expected length of hospital stay for the patient’s diagnostic related groups involved. Target variables in the study were early-readmission rate (30 days) and mortality. A detailed description of the deployment of the service as mainstream service with a pragmatic approach has been reported elsewhere [29].

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2.6.4. Support to remote diagnosis The service [30] was conceived as a transversal program to analyze the potential to transfer specialized diagnostic capabilities into primary care. The studies were centered on a novel approach providing remote web-based support to primary care to achieve high quality forced spirometry. Eligible subjects were patients with respiratory symptoms visited in primary care and citizens at risk for chronic obstructive pulmonary disease (COPD), who were offered the test in community pharmacies [31]. Main target variables were achievement of high quality testing, accessibility to quality-certified testing across the health system and cost-savings.

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3. Results

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The core technological output of this study is an ACM system (LinkcareÒ), released under a Creative Commons license, based on (i) patient-centered management via agreed Integrated Care Protocols (ICP); (ii) enhanced patient accessibility, and (iii) technical support to improve coordination of professionals across

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2.6.1. Wellness and rehabilitation Main objectives of the service were twofold: (i) to achieve longterm sustainability of training-induced increase of aerobic capacity in clinically stable chronic patients; and, (ii) to empower patients for self-management enhancing patient’s daily physical activity and healthier life-styles. All patients were studied at baseline, immediately after an 8-week endurance training program and at the end of at least 12 months follow-up. After the endurance training program, the patients were allocated either to intervention (ICS) or to control (Usual Care). The study was conducted as a non-randomized controlled trial due to the complexities of the mobile technology developments during the early phase of NEXES. Target variables were aerobic capacity (six minutes walking test) [24]; health-related quality of life [25,26] and daily-life activities (modified Baecke’s Questionnaire) [27]. A detailed description of both design and the validation of the service can be found elsewhere [28].

2.6.2. Enhanced care for frail chronic patients The service was deployed using a three-step approach, as indicated in Table A.1. Firstly, we performed one randomized control trial assessing prevention of hospitalizations in frail patients with high-risk for hospitalization [29]. Thereafter, the site deployed the service as mainstream care in the Integrated Care Unit and later in the Respiratory Department. Finally, we performed an observational study on patients under Long-Term Oxygen Therapy (LTOT) aiming at exploring specific functional requirements for the management of frail/complex patients in the community. We identified this niche of patients as representative of the complex transactions among all community actors involved in an integrated care scenario [29].

Fig. 3. Core functionalities of the LinkcareÒ. Based on patient-centered ICS, LinkcareÒ provides key technical elements for organizational interoperability between healthcare professionals from various tiers of care and enhances accessibility and proactivity of both patients and caregivers. This is thanks to specific functionalities attached to LinkcareÒ via interoperability middlewares. These functionalities facilitate access via the support center and portals. The traditional call center functionalities are enriched with novel patient gateways and portals for healthcare professionals. Other interesting features are patient empowerment for self-management of his/her condition with remote monitoring, integration with site-level Electronic Health Records (EHR) and automated clinical decision support.


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healthcare tiers, considering ICS conceptual and logical models as archetypal coordination models. Overall, LinkcareÒ organizes the work of case managers and others involved in the case (called the case management team) allowing communication among the case management team (through multiple channels: telephone, email, instant messaging, desktop conference, and other technologies) toward completion of goals (also called tasks), and allowing the scheduling of timelines for performing such activities. Furthermore, LinkcareÒ allows any goal to be modified, added, or removed by the case manager without requiring special skills. Moreover, a large variety of user configurable reports for communicating case status is also available in LinkcareÒ. With respect to audit and security, LinkcareÒ keeps time-stamped records of every change that happens in and around the case, and ensures that the case manager is in complete control of who is authorized to access the case folder. Main functional requirements successfully covered by the LinkcareÒ ACM system are highlighted in Textbox 1. Ò

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Textbox 1 List of requirements covered by the Linkcare ACM system.

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R1. Supports the clinical process logics of Integrated Care Services. R2. Highly customizable to both patient and site characteristics. R3. Technical interoperability with Electronic Health Records across healthcare tiers, using interoperability middlewares for HIS-specific integrations or via Health Information Exchange data exchange processes if in-place. R4. The implementation does not require replacement of pre-existing proprietary Electronic Health Records. R5. Collaborative tools to facilitate interaction between users with different profiles and levels of care making operational the service workflow. R6. Open source. R7. Three-tier architecture to facilitate integration with provider-specific HIS. R8. Support for integration with current Clinical Decision Support Systems for automated quality-certified spirometry testing. R9. Web-service integration with knowledge management tools to provide case data query and analytics for biomedical researcher. R10. Potential for bridging with informal care by means of a patient gateway with self-management applications.

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To cover the above functional requirements, core functionalities (Fig. 3) of LinkcareÒ include: ICSs management with web-based and user-friendly portals for healthcare professionals and for patient empowerment for self-management, integration with provider-specific EHR, interoperability with remote monitoring devices (by means of the Linkcare Mobility Android App [32]), integration with clinical decision support systems, incorporation of support center functionalities and delivery of educational resources. It is of note that integration at site level should be provided by the local systems integrator using, if available, local or regional Health Information Exchange. In the following sections, we take a generic ICS to describe the user roles, how an already existing generic ICS is managed and executed and what are the functionalities and software architecture principles LinkcareÒ.

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3.1. ICS management and execution

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Once the logical model of the ICS has been instantiated with the ICS editor, and after its incorporation to LinkcareÒ, healthcare professionals can start the management and execution of the ICS. Depending on their role in the given ICS, professionals will have different access and operational rights. The general conceptual workflow for ICS planning and execution, depicted in Fig. 4, expands the ICS Work plan definition stage, into two functions: Work plan customization and Task assignment, allowing to better differentiate between the customization of the work plan template to patient-specific conditions and the planned management of both tasks and healthcare workforce. The technological implications of these stages and their functional workflow are described in detail below.

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3.1.1. Case identification This first step allows labeling a new case as eligible for case management, still with no selection of a specific ICS instantiation, which will be performed by the same or another healthcare professional during case evaluation. Patient information stored in external provider-specific EHR can be retrieved at this stage to ease case identification.

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3.1.2. Case evaluation In this step, professionals gathers information from patients with a twofold aim. Firstly, patient’s inclusion into the ICS instantiation that best fits his/her profile and, secondly, comprehensive assessment of the case to facilitate the work plan definition. Patient inclusion is associated to eligibility established through manual completion of checklists composed of clinical guidelines and well-established profile and examination questionnaires available on the library of forms (see Section 2 – Forms Library in Appendix B). In addition, healthcare professionals can have access to the history of previous disease episodes stored in the corporate EHR and the history of previous and current ICS admissions to support case evaluation, ultimately leading to the next stage for Work plan definition or discarding the case if not eligible.

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3.1.3. Work plan definition The work plan can be built from scratch or based upon an ICSspecific predefined work plan. As mentioned above, we distinguish the following two sub-stages: (i) Work plan customization - this stage allows the selection of specific tasks to personalize the predefined work plan to patient-specific conditions and needs. The library of tasks available, designed and evaluated in NEXES [10], included: informative documents supporting diagnosis, treatment and ICS management, electronic forms, tasks associated to the support center (i.e. phone calls, SMS messaging, videoconferencing, etc.) and patient remote monitoring using either electronic questionnaires or wireless sensors of vital signs; and (ii) Task Assignment – it corresponds to scheduling and allocation of tasks to the individual professionals of the team (e.g. healthcare professional, patient, social worker, etc.) taking into account the agenda of individual members of the care team. Otherwise, ICS optional tasks have a predefined task leader and can be performed anytime.

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3.1.4. Follow-up and events handling This stage corresponds to the running and management of a given ICS in a particular patient until its termination. In addition, this step encompasses event management. Events are generated by the patient (case) or by professionals (issuer agent) and registered to the system by healthcare professionals (poster agent) to request a service or advice to another professional or team (assigned agent). Events can be also generated because of the

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Fig. 4. LinkcareÒ workflow for ICS management and execution. The corresponding ICP template is used as a library of resources for the correct customization and execution of the ICS workflow. Integration with corporate EHR allows instant access to required patient information for case identification and evaluation, avoid data duplicity and preserve the current corporate clinical data chain of custody. Follow-up and discharge reports can also be sent to the corporate EHR to keep trace of the ICS execution as part of the patient clinical episodes.

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findings reported in a task. A specific event called Second Opinion allows requesting collaboration with other LinkcareÒ users. During the execution of the ICS work plan, follow-up reports can be generated and delivered to be stored in an external EHR. The continuous patient’s assessment during this phase may lead to changes in the working plan triggered by unexpected events. Patient self-management is a crucial part of ICSs. Accordingly, LinkcareÒ supports patients’ empowerment with a web-based patient gateway, which allows patients access to their optional and scheduled tasks, to review their follow-up, to check educational information, to share documents of their choice with its case manager and the remote monitoring of patients’ vital signs.

3.1.5. Discharge Once the assigned ICS working plan is completed, the patient can be discharged or re-evaluated to be included in a different ICS. The ICS execution can also be terminated by patient’s voluntary decision or by a change in the personal or health conditions that would make him/her no longer eligible. Ultimately, patient discharge reports are generated and sent to the corresponding EHR.

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3.2. System architecture

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LinkcareÒ acts as a common interface exposing only the relevant information and interfaces of the underlying applications to the end-user. To this end, the system uses a component-based three-tier architecture as depicted in Fig. 5. The three-tier architecture consists of the following presentation, logic and data tiers.

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3.2.1. Presentation tier The presentation tier is composed of (i) a set of separate web portals for ICS management and execution (professionals portal), for team management, for call center operators (automatic call identification and call event processing), for patient self-management (self-explorations, educational material and event posting), the ICS Editor, and for system maintenance; and (ii) an Android application [32] to allow self-explorations and remote measurements using wireless medical device.

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3.2.2. Logic tier The logic tier dispatches through a SOAP web service bus all user-interface transaction requests. This allows easily embedding LinkcareÒ into existing corporate systems (in-place HIE if available) and provide a mean to facilitate privacy-preserving health data mining. All web service requests are properly recorded for data access tracking purposes and audit. The SOAP web services are divided into five main categories (see Appendix B for a comprehensive technical specification of the currently available web services). System Services are designed to provide system parameters, such as language lists, multilingual descriptions, roles, source references, etc. Session services are used for session persistence acknowledgment. Center services provide organization information of a particular center, such as center-associated users, users and user’s roles. Centers can be associated to other centers, and grant them access or administrative relations, so users who belong to different organizations can access the shared clinical data. Library services allow access to the resource library. The main library resources are the ICP templates, the work plan templates and the ICS available tasks. Finally, Clinical Data Bank Services

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Fig. 5. Three-tier architecture of the LinkcareÒ. This multitier architecture allows separating the presentation or graphical user interface, business or application and data management logics, which permits the option of modifying or adding a specific layer, without reworking the entire application, in response to changes in requirements or technology.

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anonymously store and exchange clinical information of cases. LinkcareÒ maintains a list of case identifiers that point to one or more health care information systems to retrieve the personal data. However, the personal data itself is not stored in LinkcareÒ, and each user access to such data is retrieved from the related source in real time, passing the user’s credentials for that particular source.

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3.2.3. Data tier Finally, the data tier anonymously records all task and event execution information in a local or cloud database management system. Interoperability with clinical data is ensured by supporting different sets of terminology (i.e. International Classification of Diseases, ICD-9CM; SNOMED) and the HL7 2.5/3 standard for exchanging information between medical applications. A detail description of the system software and hardware requirements is provided in Appendix B.

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3.3. System usage and performance

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The overall assessment using MAST [23] showed readiness for a successful deployment of ICS in the Barcelona healthcare district wherein NEXES was conducted [29]. The characteristics of the integrated care services in which the system was used and a summary of main MAST assessment outcomes are summarized in the following Table 1 and presented in more detail in Appendix A.1.

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3.3.1. Wellness and rehabilitation A total of 173 cases were managed with this ICS during the NEXES project lifetime. LinkcareÒ allowed to effectively support the process logic of this ICS (detailed as a BPMN diagram in the Appendix A.2) but also supported patient empowerment to manage his/her healthcare conditions via a web-based personal health folder and delivery of motivational SMS messages, as well as the use of a mHealth solution to remotely monitor pulse oximetry. Moreover, the modular design of LinkcareÒ facilitated its integration with the call center of the Integrated Care unit of the Hospital to bring contextual information of a case when calling to his/her a case manager. The ICS showed potential to maintain

training-induced enhancement of aerobic capacity over time (p < 0.01) and had a significant positive impact on both health-related quality of life (p = 0.03) and daily physical activity (p < 0.05). The role of the personal health channel, as a simple and robust offline ICT support to enhance patient adherence to the program [28], should be highlighted. The service requires further validation through a large cost-effectiveness study before being considered as candidate for regional deployment.

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3.3.2. Enhanced care A total of 848 cases were managed with this ICS using LinkcareÒ, as detailed as a BPMN diagram in the Appendix A.2. This ICS effectively supported the use of a mHealth solution to remotely monitor his/her vital signs and to fill electronic forms. Moreover, integration with the call center was also provided. An initial randomized control trial assessing prevention of hospitalizations in high-risk frail patients showed positive impact on patient survival (p < 0.05), markedly decreased unplanned hospital admissions and allowed identification of barriers for transfer of the service to primary care [29]. The deployment of the service as mainstream care generated cost-containment. Moreover, the observational study on patients with Long term Oxygen Therapy helped to set the basis for community-based regional deployment of the integrated care services for chronic patients. Overall, the analysis of the Enhanced Care results recommend the deployment of four different integrated care services under the umbrella of the program, that is: (i) Prevention of Hospitalization in frail chronic patients with high risk for admissions, as assessed in the project; (ii) Transitional support after hospital discharge; (iii) Community-based integrated care service for clinically stable frail chronic patients; and, (iv) Palliative care.

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3.3.3. Home hospitalization and Early Discharge A total of 2314 cases were managed through LinkcareÒ (the process logic is detailed as a BPMN diagram in the Appendix A.2), supporting professional accessibility at patients home through a mobile workstation, as well as its integration with the call center. The ICS deployment as mainstream service clearly showed enhanced health outcomes in terms of a mean of 5-day reduction

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Table 1 Summary of the ICS assessment. W&R (173) Study design ICT Main results

MAST multidimensional assessment Pragmatic (8-w T + 22 m) (173) PHF/Smartphone-SaO2/SMS Sustainability of D 6MWT (p = 0.01) improvement of SGRQ (p < 0.01) Daily physical activity (p = 0.03)

D1 D2 D3

Safe. No patient discomfort Efficacy (See W&R main results) Patients satisfaction using PHF than only SMS and professionals agreement with the setting

D4 D5

Cost-effectiveness analysis needed Need to define characteristics of mainstream service and its organizational impact Regulatory issues to articulate informal (PHF) and formal care (EHR) pending High level of transferability

D6 Lessons learned EC (848) EC-Prev. Hosp. Study design ICT

Main results

Transferability. Larger RCT

RCT (1-yr follow-up) (155) Support Centre + Smartphone + sensors + Forum Clinic.Laptop for home visits. Improvement of Self-management (p = 0.02), HAD (p = 0.001), SGRQ (p = 0.02) and reduction of ED visits (p = 0.02) and mortality (p = 0.03)

D7 MAST multidimensional assessment D1 D2

D3

D4 D5 D6 Lessons learned Enhanced Care Deployment (n = 287) and LTOT (406) see text and [29] HH/ED (2314) Study design ICT Main results

Need for health risk stratification and work force preparation

D7

MAST multidimensional assessment Pragmatic (2404) D1 Call Centre/Laptop for home visits D2 Mean reduction of 5 in-hospital days per D3 patient (p < 0.01) and early-readmissions (10%). Cost savings D4

D5 D6 Lessons learned

Support (7793) Primary Care Study design ICT Main results

Safe option for a significant % of patients. D7 Synergies with other ICS were demonstrated

RCT (4581 – respiratory) Web based CDSS High Quality Testing (p < 0.001)

MAST multidimensional assessment D1 D2 D3

Lessons learned Pharmacies Study design ICT Main results

D4 D5 D6 Strategy for regional deployment D7 MAST multidimensional assessment Cross-sectional (3466) D1 COPD Case finding (smokers) D2 Web based support High Quality Testing D3 (>70% tests) D4 D5

Lessons learned

Strategy for regional deployment

D6 D7

Within safety zone and no technical threats. Efficacy, but two factors limiting effectiveness for community-based deployment: (i) workforce preparation; and, (ii) individual risk assessment and stratification Positive global patients’ satisfaction – SUMI score of 63 (CI 58.8 to 66.2), and professionals acknowledged empowerment role in the different tasks Favorable cost-effectiveness incremental ratio Incentives for adoption are important and novel payment modalities (e.g. bundle payment) Data privacy for information transfer was ensured Transferability to community should be enhanced through lessons learned

Safety associated to patient eligibility criteria Effectiveness (see HH/ED main results) High rate of patients’ satisfaction (95%). Professionals required improvement of usability Cost-effectiveness at health system level. Need for reimbursement incentives and bundle system at provider level Need for shared-care agreements between hospital and community Technical functionalities compliance with ethical and legal regulations Transferability modulated by existence of collaboration between hospital and community, reimbursement models, and ICT-supported collaborative tools

No clinical or technical safety concerns High levels of effectiveness (see main results) Patient perspective does not apply to this study. Professionals showed satisfaction (86% (n = 126); score 7.3/10) Cost-effective No major impact on organizational aspects No socio-cultural, ethical and/or legal issues Highly transferable No clinical or technical safety issues were raised Results equivalent to Primary Care Patient perspective does not apply to this study. Professionals satisfaction Cost-effectiveness analysis needed. Need for a dedicated area for the performance of the spirometry in Pharmacy offices No major ethical-regulatory issues High transferability

Legend: Number of patients within parenthesis; Wellness and Rehabilitation (W&R); Enhanced Care (EC); Prevention of Admissions (EC-Prevention Admissions); Long Term Oxygen Therapy (EC-LTOT); Home hospitalization and Early Discharge (HH/ED); Remote support for diagnosis (Support); 8-week Training program and follow-up after training (8-w T + Xm); Personal Health Folder (PHF); Information and Communication Technology (ICT); Randomized Controlled Trials (RCT); SaO2 (oxygen saturation pulse oximetry); Short Message Service (SMS); messaging services using ELIN platform (e-Messing and Bi-m calls); Information Technology (IT); Anxiety & Depression (HAD); Saint George Respiratory Questionnaire (SGRQ); Emergency Department (ED); web-based patient education (web-based Forum Clinic); Clinical Decision Support System (CDSS); Confidence Interval (CI); D1: Clinical and technical safety; D2: Clinical effectiveness; D3: Users’ perspectives; D4: Economical aspects; D5: Organisational aspects; D6 Sociocultural, ethical and legal aspects, and D7: Transferability.


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in in-hospital stays with a low rate of early readmissions (10%), economic sustainability at provider level and marked savings at health system level [29].

580

3.3.4. Support A total of 7793 cases were managed with this ICS allowing to effectively supporting the process logic of this ICS in primary care and in pharmacy offices (detailed as a BPMN diagrams in the Appendix A.2). It also facilitated its integration with a broad range of provider-specific wireless spirometers via an interoperability middleware. The remote support to high quality forced spirometry testing in primary care substantially quality of the testing (p < 0.001) [33] and generated a mature frame for regional deployment of the service.

581

3.4. Lessons learned for regional deployment of personalized care

582

Although LinkcareÒ covered the requirements for deployment of the NEXES’ field studies [29], characterization of the driving forces at site level and identification of dominant barriers for the change are pivotal elements to be taken into account in the process of site adaption of the deployment strategies. To this end, the overall strategy for deployment should be based on a building blocks approach focusing on short-term outcomes that generate continuous feedback and iterations, which may help to refine the following key challenges of the deployment process: technological aspects, organizational setting, ethical and regulatory issues, and business models. One of the key technological challenges for regional deployment of LinkcareÒ was the support of multi-provider interoperability for the secure, reliable and systematic exchange of health information across different healthcare providers while supporting shared ICS processes. In those regions where initiatives for health information exchange are in-place (e.g. the WiFiS interoperability framework [34] in Catalonia), LinkcareÒ should be articulated correspondingly (with proper integration of the presentation and data tiers), while in regions were sectorial platforms for health information exchange do not exist, the LinkcareÒ can also provide technological support for health information exchange. Additional technological challenges for regional deployment should account for the enrichment of the personal health folder (health channel) assessed in NEXES [28], evolving to mobile applications that make use of MobileID solutions to ease citizen’s access to their personal health folder. Such mobile applications, if properly accredited in the regional patient gateway (Cat@Salut [35] in Catalonia) and articulated with the regional shared electronic health records (HC3 [36] in Catalonia), may cover a twofold aim: (i) the articulation of non-clinical (informal care) and clinical information (healthcare); and, (ii) the empowerment of patients for self-management. In this respect, articulation between informal care and healthcare, should allow the incorporation of non-clinical information into patient management; that is, data on patient adherence profile, lifestyle (physical activity, nutritional habits, addictions, etc.), social support needs and environmental and societal factors that have a well-accepted impact on health status and survival. Moreover, the articulation of this scenario with systems-oriented biomedical research systems, ensuring continuous cross-fertilization between research and patient care, should support the incorporation of non-biomedical data into predictive modeling and should provide dynamic modeling approaches, facilitating the way toward truly personalized medicine for patient health-risk assessment and stratification [37]. As an example, the SynergyCOPD project [38] identified that oxidative stress may play a central role in COPD patients (e.g., with moderate to severe functional impairment and active disease both at pulmonary and systemic levels (skeletal muscle dysfunction/wasting) and co-morbid

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conditions (metabolic syndrome and cardiac failure) such that research professionals (with translational clinical and basic background) cooperate to further explore other poorly known mechanisms and to generate combined biomarkers to assess novel therapeutic strategies in the clinical scenario, ultimately leading to the generation of novel rules that should feed in-place CDSS. However, although the logical tier of the LinkcareÒ ACM system provided web-service integration with knowledge management systems [39] to provide case data query and analytics for biomedical researcher, no real use-case scenarios exist during any of the four ICS studies. A proper integration with biomedical research will require stepwise implementation strategies wherein two key aspects clearly emerge as main short-term priorities. Firstly, the convergence of on-going developments in the area of knowledge management fostering the bridging between omics-generated knowledge and the clinical arena, and ICT developments aiming at generating user-friendly portals for clinicians devoted to translational research. Finally, progresses in the integration of ACM systems with biomedical research platforms will be strongly associated to: (i) strategies fostering convergence of both open and proprietary approaches considering the design of innovative business models providing sustainability of biomedical research platforms beyond specific research and/or infrastructure projects that triggered the initial settings; (ii) proper consideration of both legal and ethical aspects ensuring privacy and security of data transfer and management and allowing the use of data for purposes other than the original data collection aims. In summary, future ACM systems (e.g., LinkcareÒ) should consider the articulation of open and modular tools supporting organizational interoperability, and appropriate functionalities, among the three main areas illustrated in Fig. 6, namely: (i) informal care (e.g. life style, environmental and behavioral aspects, etc.), (ii) formal care, and, (iii) biomedical research.

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4. Discussion

664

4.1. Technological achievements

665

The current study describes the characteristics of LinkcareÒ, an open and modular ACM system conceived to cover the requirements for deployment of integrated care services and tested in the context of the NEXES’ field studies [10]. LinkcareÒ has been operational during the project lifetime in one of Barcelona’s Health Care Districts accounting for 540.000 inhabitants, showing potential for further deployment at regional level. Overall, LinkcareÒ adopts the ACM model to support the process logic of integrated care, allowing patient-centered management with high potential for both patient-specific and provider-specific customization. Moreover, LinkcareÒ has adopted a Health Information Sharing (HI-Sharing) approach that allows sharing data over complex processes without having to make changes to the corporate HIS or EHR data structures. In this sense, all patient information gathered and managed by LinkcareÒ is reused, if possible, from existing EHRs. Otherwise, new data entered to the system (e.g. patient remote monitoring measurements, patient answers to questionnaires, etc.) can be then delivered to the corresponding EHR. Within this scenario, LinkcareÒ acts as a common interface, on top of Health Information Exchange (HIE) systems if in-place, with functionalities that facilitate electronic health information that is properly integrated based on the agreed ICS workflow.

666

4.2. Challenges for large-scale deployment

688

The experience gathered in the other two NEXES sites, Athens and Trondheim, was extremely useful to identify those conditions

689


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Fig. 6. Conceptual framework for the regional deployment of personalized care. With respect to formal healthcare, in-place health information exchange (e.g. the WiFiS interoperability framework in Catalonia [34]) will lead the integration of basic highly standardized processes, namely: medical appointments, clinical data exchange, medical referral, etc., among healthcare providers with heterogeneous proprietary systems (moreover, it could also perform sectorial message routing and message delivery control); while ACMS (e.g. LinkcareÒ) will support novel Integrated Care Services. Regarding informal care, citizens can access their health related data via a Personal Health Folder (e.g. Cat@Salut [35] in Catalonia) articulated with regional shared electronic health records (HC3 [36] in Catalonia). The PHF can also act as the citizen entry point for some of the supported processes (e.g. Medical appointments, participation in ICSs, etc.) and informal health data sources (e.g. mobile health applications, community medical devices, etc.). Finally, Biomedical research platforms providing knowledge management strategies, profile-specific visual data mining functionalities and profile-specific environments supporting multi-scale predictive modelling and several forms of complex data analytics. Ultimately, this conceptual framework should lead to different levels of stratification and personalized therapeutic strategies guided by clinical decision support systems.

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wherein the implementation of LinkcareÒ may show different types of limitations. In Norway, NEXES was deployed in the Central Norwegian Region Health Area (CNRHA) as part of the preparatory phase of the Coordination Reform [40,41]. Since the very beginning of the project [10], however, it became apparent that the Norwegian legal frame on health data transfer precluded the use of LinkcareÒ for deployment of the four ICS (i.e., in Norway a health provider is only allowed to hand over (not give access to) information and merely information that is relevant in the particular episode when requested by another provider and after checking if the provider fulfil requirements defined by the law). Instead, an alternative nationwide platform based on exchange of electronic messaging among providers (HIE) was used. During the project lifetime, it has been shown that technological support of ICSs based on a pure HIE approach constitutes a clear limitation for the deployment of integrated care being a significant explanatory factor of the lack of effectiveness of the interventions on the Norwegian site in W&R and EC. Thus LinkcareÒ should facilitate the extensive deployment of integrated care following the implementation strategy developed within NEXES for the transfer from a HIE setting to a HI-Sharing in Norway (see Appendix B). However, a first step, necessary for a successful introduction of integrated care in Norway, is to open up the EHR in Norway should consist on providing a legal framework that allows broader access to HER data by different legal entities in the same working area. In Greece, a core initial version of LinkcareÒ was used to support the NEXES field studies as an standalone application because of the lack of a fully operational HIS in place, at least until 2011. The project in Athens was developed by qualified and motivated early adopters of ICS and it provided valuable information for deployment of chronic care in a highly fragmented health system. One of the main NEXES’ outcomes was the analysis of the interplay among different dimensions (organizational, technological, business model, ethical-regulatory, etc.) that may modulate the

success of deployment of integrated care services in heterogeneous scenarios involving different healthcare providers. In this regard, the project generated further evidence beyond that obtained from previous deployment experiences generated by a single healthcare provider [8,9], as already mentioned in the Introduction. The experience gained in NEXES should be useful for planning regional deployment of integrated care at the European level.

726

4.3. Future developments

733

As already discussed in the manuscript, at the end of the development process, the inherent conceptual and logic models of LinkcareÒ showed major compliance with the ACM model. However, it has not been since very recently, that the Object Management Group (OMG) has released a first version of its Case Management Model and Notation (CMMN v1.0) specification [13], which defines a common meta-model and notation for modeling and graphically expressing ACM, as well as an interchange format for exchanging Case models among different tools. Is for this reason that a previous BPM standard (i.e. the BPMN formalism [11]) was used to create the process logic of the ICS care plans for individual patients and to formalize the core functional requirements of LinkcareÒ. Although there are currently mechanisms for a CMMN model to invoke BPMN and it might make sense to combine the two modeling standards, it seems reasonable that any future ACMS should claim compliance or conformance with CMMN v1.0. Furthermore, LinkcareÒ can be used for not only patient management, but also it can also have a role as knowledge sharing tool across healthcare sectors. Most importantly, it can evolve as a platform bridging healthcare sectors with informal care (i.e. life style management or case finding programs run by informal careers) [31,33] through integration of the personal health folder already assessed in NEXES, as part of the Wellness and Rehabilitation ICS [28]. Moreover, LinkcareÒ also shows possibilities as a tool

734


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bridging formal healthcare with bioscience research [37,42]. All this potential leads to new exciting challenges that will need to be faced to successfully pave the way for the development of the future 4P (Predictive, Preventive, Personalized and Participatory) medicine for patients with chronic conditions.

764

5. Conclusions

765

775

The LinkcareÒ ACM system successfully provided technological support for the management of the four complex ICS assessed in NEXES [29]. LinkcareÒ facilitates large-scale deployment of integrated care because it fosters the transfer of complexity from specialized care to the community and to patients’ home. The adoption of the ACM model for ICS management has proven to be a useful approach to design Integrated Care Protocols (ICP). Unlike the classic BPM formalism, that requires specialized skills on BPM notation principles, ACM foundation concepts allows health care professionals to design ICP, and customize them for personalized medicine purposes.

776

6. Conflict of Interest

[10]

777 778

Jim Roldan is the CEO of Linkcare HS. AA, CH, FB, JIM and JR have Linkcare HS stocks.

[11]

779

Acknowledgments

[12]

780

[13]

808

The study have been funded by the NEXES European project (CIP-ICT-PSP-2007-225025), the PITES national project (PI09/ 90634 and PI12/01241) and AGAUR 2014-SGR-661. Special thanks to the NEXES consortium: Hospital Clinic de Barcelona – Institut d’investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Catalonia. Josep Roca (Project Coordinator), Albert Alonso, Anael Barberán, Felip Burgos, Isaac Cano and Carme Hernàndez. Central Norway Regional Health Authority (CNRHA), Trondheim, Norway. Anders Grimsmo, Arild Pedersen and Sigmund Simonsen. Trondheim City Council, Trondheim, Norway. Helge Gåresen, Klara Borgen. Saint Olav’s Hospital HF, Trondheim, Norway: Stian Saur. 1st YPE of Attica – Sotiria Hospital, Athens, Greece: Theodore Vontetsianos, Alexis Milsis and Thodoris Katsaras. 1st Department of Respiratory Medicine, National and Kapodistrian University of Athens, Athens, Greece: Ioannis Vogiatzis. Santair SA, Athens, Greece: George Vidalis. Linkcare HS, Barcelona, Catalonia: Joan Ignasi Martínez (JIM) Roldán. Stiftelsen Sintef, Trondheim, Norway: Babak Farshchian, Joe Gorman, Leendert Wienhofen. Intracom Telecom, Athens, Greece: Ilias Lamprinos Fundació TicSalut, Barcelona, Catalonia: Josep Manyach and Montse Meya. TXT e-solutions, Milano, Italy: Salvatore Virtuoso. Telefónica I+D, Barcelona, Catalonia: Jordi Rovira.

809

Appendix A. Supplementary material

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Supplementary data associated with this article can be found, in the online version, at http://dx.doi.org/10.1016/j.jbi.2015.02.011.

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