CHIRON INTEGRATED HEALTHCARE APPROACH FOR HOME, MOBILE AND CLINICAL ENVIRONMENTS
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The CHIRON Work plan

The CHIRON Project is planned to run for three years. The project can be divided into three major phases:
Phase 1: Identification of the user needs and of the functional requirements – Definition of the specifications and design of the CHIRON Architecture (months M1-M12);
Phase 2: Development of the technical components (M6-M24);
Phase 3: Integration of all the subsystems into the whole CHIRON system and verification through performance testing and field trials (M22-M36).
From a temporal point of view the various phases will have some areas of overlapping and the first outcomes of the verification activities will be used for a refinement of the development in an iterative approach.
The activities of the project have been organized in nine work packages; the following figure shows the work plan for the CHIRON project

The structure of the Chiron Project

WP1 will deal with functional and non functional requirements including user interfaces. The work package will collect the user requirements, translate them into functional system requirements and create the overall system architecture. By following an User-centered Design (UCD) approach, all the stakeholders will be involved in the capture of the user requirements (the patients, their families, the caregivers (informal and formal) , the medical institutions and the whole community). User Forums and Workshops will be organized. The reference architecture developed in this WP will address all these needs and will be discussed extensively in a workshop involving also the CHIRON Scientific Advisory Board.
CHIRON architecture will be driven by quality attributes crucial to address the aims of the Project; the focus will be on:

  • efficiency (resource utilization including workload distribution, processing capacity and information distribution),
  • portability (adaptability of data structures, to HW devices and network facilities, organizational environment adaptability, system software environmental adaptability),
  • reliability and recoverability,
  • security.

In designing the CHIRON architecture the basic questions to be answered are the selection of appropriate basic technologies, the definition of interfaces which will enable easy integration of individual CHIRON components as well as exchange of components to allow for adaptation of the functions supported by the CHIRON system.
It is planned to use formal methods such as MSC/UML to specify the overall architecture and to simulate the architecture in very early stages and to allow for easy evolution of interfaces.
The following graph shows how the architecture will be conceived and finalized.

Iterative approach in finalizing the CHIRON architecture

A starting point will be analysis of the state-of-the art: general purpose embedded platforms such as those based on Sunspot9, MicroLEAP10, Texas Instruments EZ 43011 will be considered together with works specifically devoted to wireless health platforms (UbiMon12, SPINE13, Code Blue14, MobiHealth15).
These architectural proposals show some weaknesses and among the others a lack of integration with the clinical workflow, a lack of synergic sharing of multisource information and previous medical knowledge, a lack of flexibility and adaptability to the integration of multivendor solutions, a lack of personalization.
To cope with the heterogeneous nature of its components, the architecture must be both effective and generic. CHIRON intends to provide a modular plug-and-play middleware in which applications and devices can be built upon and multiple sources (and repositories) of data can be integrated following an orchestration approach.
The analysis of the application and of the user requirements will bring a series of critical issues to be addressed in the definition of the CHIRON architecture. The following list is for illustration only and is not intended to be comprehensive:

  1. ubiquitous and mobile use;
  2. resource restraints at the wireless sensor network level (e.g. reduced bandwidth in the connection with the wireless device of the patient and need for effective data compression techniques, energy and lifetime of the wireless mobile components, limited computational capabilities of the mobile device);
  3. networking security and information privacy;
  4. “medical accuracy” of the gathered data / info;
  5. Reliable and robust expert systems;
  6. Integration of multisource information such as clinical data, medical history of the patient, info on allergies, vaccination and other personal info;
  7. Integration of personal health into the clinical workflow;
  8. Standardization;
  9. Usability, acceptance of the solution,
  10. Personalization of the solution.

Finally – even if its solution is beyond the scope of the CHIRON Project – we will need to address the enormous problem related to the availability of suitable Healthcare IT infrastructures.
As highlighted by various experts, “digital healthcare problems can not be resolved without IT infrastructures” that will allow the sharing of information among providers, hospitals, clinics, radiology centers, patients.

WP2 and WP3 deal with the User Plane of the CHIRON Platform and will develop the hardware for the new sensor nodes16, as well as the interfacing between sensor components and the local data processing and feature extraction.
The challenging objectives are to obtain appropriate sensing mechanisms with sufficient sensitivity and specificity while keeping low form-factor, to incorporate computationally light noise removal, artefact separation and feature extraction algorithms within the sensor nodes and to ensure long operational lifetime by application of novel ultra low-power design technique supported by energy harvesting.
An exploration of appropriate radio system under the perspective of data volume and data rate required will be carried out and accordingly appropriate radio system will be deployed for each of the sensors.

Furthermore the WP3 will develop solutions for a first elaboration of the data, the definition of a Personalized Health Risk Assessment model and the activation of first feedbacks to the patient (Alter Ego model). It will include personalized educational contents (warning messages, reminders, health coaching material, etc.) by using the motivational approach most suited to the psychological profile of the patient. The objective is to motivate and empower the patient to manage his own disease. Emergency call will be activated in case of critical evolutions.
The feedbacks will be activated locally according to a risk assessment of the patient (the Alter Ego model) that is personalized, evolving and adapted to the changing context.
An intelligent classifier will enrich semantically the sensor data and will allow the unambiguous determination of actions.

WP3 will deal also with distributed storage of data at the sensor node level and novel data compression techniques.

WP4 designs and develops the network infrastructure and communication protocols between the User Plane and the Medical Plane i.e between the personal healthcare system and the clinical workflow. Data security and privacy issues will be addressed in this WP. It is important to notice how the various layers of the CHIRON platform interact and interchange information between each other: the User Plane sends the gathered information to the Medical Plane and receive from it feedbacks and eventually instructions for the adaptation of the monitoring system (e.g., new parameters added, measurement frequency changed) by creating in such way a first loop. The medical plane transmits elaborated data to the statistical plane by enriching its repository and receives from it information related to past knowledge, supporting the medical professionals in their decisions (second loop) that then will have a further impact on the therapeutic treatment program of the patient (third loop).
This task will also ensure efficient data transmission in heterogeneous communication networks and integrating different wireless sensor network technologies in order to be transparent to the user. In the CHIRON architecture the concept of cross-layer optimization will play a crucial role. In order to cope with these issues, a new abstraction layer will be designed ; it comprises the minimum needed sub layers to seamlessly access the exposed services of heterogeneous networked embedded devices of limited resources so as to improve and speed-up the development of a wide spectrum of new person-centric and context aware services. More specifically, the abstraction layer will expose a generic device profile to the application layer and provide a standard mechanism to access data and services of heterogeneous networked embedded devices independently from the hardware of the nodes and from the specific solution adopted at network and link layers.
In WP4 a middleware for interaction between User Plane, Medical Plane and Statistical Plane will be developed too. Finally solutions to ensure privacy of the data generated in the User Plane will be considered and fully integrated in the protocol stack.

WP5 deals with the advanced medical imaging management developed to enhance productivity and accuracy in the image-based diagnostics. The WP will develop high-speed electronics and embedded software enabling real-time image processing and visualization. Fine and clinically relevant details will be automatically detected through innovative algorithms and visualized by using novel high dynamic range displays. The solution will offer an effective support to the doctor for more accurate and faster image’s interpretation. The image-related information – integrated and correlated together with all the other data of the Virtual Patient Repository of WP6 – will foster better diagnosis and therapeutic planning.
Nowadays healthcare has an image-centric approach; images are used for diagnostic purpose, for treatment planning, for image-guided surgical procedures; the optimization of the visualization of the medical images and the automated detection of suspicious structures will enhance the accuracy of the clinical tasks , will provide a valuable support to the medical professionals and will increase their productivity. Once integrated with other clinical data of the patient captured through the continuous monitoring approach of CHIRON they will provide a powerful tool for the assessment of the health status of the patient and for planning suitable treatments and therapies.
The activities in WP5 will strongly interact with the ones in WP6, since both Work Packages lie in the “medical plane”. More specifically, research performed for Tasks T5.1 and T5.2 will provide Task T6.2 with reliable results from the automated analysis of image data. Tasks T5.3 and T5.4 will yield results for T6.2 too, in an indirect way: the studied methods will improve the accuracy of the visualized image and therefore the diagnostic ability of the medical personnel. In the opposite direction, feedback from Task T6.3 will provide WP5 with suitable correcting factors based on the overall health status of the patient. The methods developed in Task T5.4 will likely lead to standardization initiatives (Task T8.3) in order to improve the DICOM standard and extend its applicability to the wider luminance range provided by he innovative display device.

WP6 will develop software for the fusion and analysis of medical data obtained from the heterogeneous subsystems (sensor networks, imaging systems) developed in WP2–5. Algorithms will analyze the multi-parametric data enriched by the personal profile of the patient, will detect degenerative trends and will activate suitable and preventative feedbacks both to the patient and to the medical professionals. Medical professionals will be assisted in the execution of their critical tasks by providing them decision support.
All the available data and information including personal data of the patient and statistical medical data will be integrated and used.
In view of the trials of the WP7, we will build a preliminary, quite simple expert system focused on CHF disease and based on a reduced number of parameters; they will be selected on the basis of past, consolidated medical experience. Additionally we will investigate on the possible impact of additional factors such as the environmental conditions (ambient temperature, humidity, air pollution).
The system will analyze instantaneous values and trends of all the parameters and will assess them according to a grid of safe, warning and critical regions. Feedbacks in terms of recommendations or emergency calls will be accordingly activated.
Even when limited to a specific case (CHF) we will need a long experimentation (2-3 years) extending over the length of the CHIRON project to fully validate the expert system. Nevertheless the first outcomes of the trials will allow to get first feedbacks and to refine the model.
Innovative technique for data security and privacy at a wide area network level will be elaborated complementing in this way the methods already introduced in the WP3 at BAN level and in the WP4 at LAN level.
Part of the activity of this WP will be devoted to the definition and implementation of a Virtual Data Repository. The Virtual Data Repository defines a virtual structure for the data and provides a common interface. This Virtual Data Repository will be important to integrate CHIRON data or parts of it in hospital information systems.
The CHIRON system has various sources of patient data in different formats. The data may be raw data gathered by a subsystem or module or interpreted data from a subsystem or module. The kind of data comprises images, videos, sensor data, genetic information, laboratory values, epidemiologic data, lifestyle information, family history, etc. and interpretations of this data. Application Programmer Interfaces, subsystems and modules need a common interface to access the data.
The CHIRON platform will be based on “hub and spoke” system and uses the concept of data integration, i.e., the system searches for data in the network and correlates patient information. There will be no central data base. A distributed approach will be used in order to exploit the local resources of the network.
In this regard CHIRON represents a comprehensive, integrated information system designed for enforcing person-centric health care. The aim is the best possible support of patient care. While the focus of the HIS is on the hospital and all data related to it, the focus of CHIRON is on the person and all data related to the person’s health.

WP7 will be devoted to the integration of the overall system and to the verification of the features of the developed solutions and of their interoperability.
The verification will focus on three main areas:

  1. The technical characteristics of the system in relation to the scientific and technological objectives of the project,
  2. The acceptability of the solution through the execution of extensive usability tests by involving relevant user groups;
  3. The medical validity (a proof of the concept) by executing clinical trials in UK and in Italy with the involvement of patients suffering from Congestive Heart Failure class III and with the coordination of the two medical partners of the CHIRON Consortium.

Moreover an overall socio-economic assessment of the Project will be included in the WP7.

WP8 deals with horizontal activities such as Dissemination, Exploitation, Standardization initiatives, IPR Management and Ethical issues Management while WP9 is devoted to the Project Coordination and Management activities.

The link between the various WPs
9Simon D., Cifuentes C., Cleal D., Daniels J., White D.: “Java on the Bare Metal of Wireless Sensor Deveces: The Squawk Java Virtual Machine, Virtual Execution Environment (VEE)” – 2006
10Au L.K., Wu W.H., Batalin M.A., Mcintire D.H., Kaiser W.J:” MicroLEAP : Energy-aware Wireless Sensor Platform for Biomedical Sensing Applications” – BIOCAS 2007, Nov. 2007, Montreal, Canada
11Bierl L.: MSP430 Family Mixed-Signal Microcontroller Application Report, Texas Instruments
12Ng J.W.P., Lo B., Wells O., Sloman M., Toumazou C., Peters N., Darz A. : “Ubiquitous Monitoring Environment for Wearable and Implantable Sensors (UbiMon)” – International Conference on Ubiquitous Comuting (UBICOMP), 2008;
Lo B., Yang G.Z.: “Key technical challenges and current implementations of bosy sensor networks” – Proc. 2nd International Workshop on Body Sensor Networks – April 2005
13Iyengar S., Bonda F.T., Gravina R., Guerrieri A., Fortino G., Sangiovanni-Vincentelli A. : “A frame work for creating healthcare monitoring applications using WBSNs” – Proc. Of the ICST 3rd Internatiomnal Conference on BAN, Tempe – Arizona, 2008.
14Malan D., Fulkford-Jones T., Welsh M., Moulton S.: “Code Blue: An ad hoc sensor network infrastructure for emergency medical care” – Proc. Of MobiSys 2004 – Workshop on Applications for Mobile Embedded Systems – June 2004;
15Konstantas D., Jones V., Bults R., Herzog R.:” MobiHEALTH, innovative 2.5/3 g mobile services and applications for healthcare” – Proc. 11th IST Mobile and Wireless Telecommunication Summit 2002, Thessaloniki – Greece.
16A sensor node is a small, autonomous device capable of sensing one or more physical dimensions, doing some pre-processing and communicating the data to other sensor nodes or to a data sink. Several sensor nodes may comprise a sensor network. Often, a sensor node consists of several modules, such as a sensor, a microprocessor or microcontroller with some memory, a communication module and a battery.
the-work-packages-list
the-list-of-the-chiron-deliverables
A description of the clinical trials planned in CHIRON is reported in the attached pdf file.
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