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<article xmlns:xlink="http://www.w3.org/1999/xlink">
  <front>
    <journal-meta />
    <article-meta>
      <title-group>
        <article-title>A Flexible Metamodelling Approach for Healthcare Systems</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <string-name>Fazle Rabbi</string-name>
          <email>Fazle.Rabbi@hib.no</email>
          <xref ref-type="aff" rid="aff0">0</xref>
          <xref ref-type="aff" rid="aff2">2</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Yngve Lamo</string-name>
          <email>Yngve.Lamo@hib.no</email>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Wendy MacCaull</string-name>
          <xref ref-type="aff" rid="aff1">1</xref>
        </contrib>
        <aff id="aff0">
          <label>0</label>
          <institution>Bergen University College</institution>
          ,
          <addr-line>Bergen</addr-line>
          ,
          <country country="NO">Norway</country>
        </aff>
        <aff id="aff1">
          <label>1</label>
          <institution>St. Francis Xavier University</institution>
          ,
          <addr-line>Antigonish</addr-line>
          ,
          <country country="CA">Canada</country>
        </aff>
        <aff id="aff2">
          <label>2</label>
          <institution>University of Oslo</institution>
          ,
          <addr-line>Oslo</addr-line>
          ,
          <country country="NO">Norway</country>
        </aff>
      </contrib-group>
      <fpage>115</fpage>
      <lpage>128</lpage>
      <abstract>
        <p>Model driven software engineering (MDSE) is an emerging methodology for software development, targeting productivity, exibility and reliability of systems; metamodelling is at the core of most MDSE approaches. Due to their complexity and plethora of requirements placed upon them, healthcare systems so far have not been adequately modeled; as a result the software developed for them su ers from high development costs and lack of exibility, and its reliability is at risk. Here we propose a metamodelling approach that captures the complexity of these systems by using a metamodelling hierarchy, built from ve metamodels, one each for user access modelling, health process modelling, process monitoring, user interface modelling and modelling of the data sources. These metamodels are coordinated with morphisms. Such a hierarchy allows us to adequately re ect the behavior and complexities of systems and how they interact with di erent stakeholders. We give details of some of the metamodels and present some suggestions for some di erent interfaces intended for two di erent users: the clinicians and the patients.</p>
      </abstract>
    </article-meta>
  </front>
  <body>
    <sec id="sec-1">
      <title>-</title>
      <p>
        Rising costs, ageing populations and increased expectations are making the
current healthcare systems in the developed world unsustainable. Numerous studies
support this claim, for instance in the US, if the trends of the last 20 years
continue, health care spending will eat up the entire GDP within the next
generation, and health care spending will eat up the federal government's budget even
sooner [
        <xref ref-type="bibr" rid="ref11">11</xref>
        ]. Information technology has the potential to support healthcare but
its application to support the continuum of care has not nearly reached its full
Copyright c 2014 by the paper's authors. Copying permitted for private and academic
purposes.
potential. Barriers include the proliferation of systems even within one hospital
(which often do not support interoperability) [
        <xref ref-type="bibr" rid="ref4">4</xref>
        ]; the fact that systems must be
highly customized to adequately serve local situations (usually a time
consuming, and error prone process); the fact that frequently adaptations to deal with
updates in medications, protocols and management strategies, etc., are
necessary; the fact that software engineering itself for such safety critical systems as
healthcare needs new strategies to ensure that systems behave correctly in every
possible scenario [
        <xref ref-type="bibr" rid="ref7">7</xref>
        ]; and the fact that many healthcare processes (e.g., cancer
care and palliative care) require a team of caregivers, involving many clinicians,
therapists and family members all with di erent needs from information
technology and with di erent, and sometimes limited, ability to handle complex
technologies. The very nature of healthcare processes di ers from typical
processes managed by work ow engines as they involve many exceptional situations,
and the sequence of tasks described by a guideline may need to be altered, at
the implementation level, in order to meet actual user needs, while maintaining
guideline intentions as much as possible [
        <xref ref-type="bibr" rid="ref15">15</xref>
        ]. The active participation of the
patient (and his/her family) in the management of his/her own health is becoming
a critical issue as the cost of chronic diseases is quickly outpacing the resources
that can be directed to healthcare.
      </p>
      <p>Model driven software engineering (MDSE) is an emerging and promising
methodology for software development, targeting challenges in software
engineering relating to productivity, exibility and reliability of systems. The
construction of various kinds of models (e.g., blueprints, mockups etc.) is a
wellknown approach in the more traditional engineering elds; these models are used
as artifacts to enable engineers to describe designs and validate whether a
proposed design has desired qualitative and quantitative properties. Metamodelling
is at the core of MDSE approaches. Here we propose that a multi metamodelling
approach is the appropriate methodology for designing healthcare systems. The
use of multiple metamodels for designing di erent aspects of a system facilitates
abstraction and require less coupling among the models; this gives us exibility
as it permits the independent remodelling of parts of the system. This paper
is a preliminary look at 5 aspects of healthcare systems, and the necessary
coordinations among them. Due to lack of space we focus our discussion on the
access control, monitoring, user access and usability aspects.</p>
      <p>
        Many di erent MDSE technologies automatically generate code from models
[
        <xref ref-type="bibr" rid="ref10">10</xref>
        ] [
        <xref ref-type="bibr" rid="ref13">13</xref>
        ]: these technologies are particularly suited for specifying the structural
aspects of software systems generally, whereas the actual behavior is programmed
manually. Some technologies for behavioural modelling in MDSE exist ([
        <xref ref-type="bibr" rid="ref2">2</xref>
        ], [
        <xref ref-type="bibr" rid="ref1">1</xref>
        ]),
but current approaches are often at a low level of abstraction and lack domain
concepts for specifying behavior [
        <xref ref-type="bibr" rid="ref12">12</xref>
        ].
      </p>
      <p>
        A collaborative group of researchers in Norway and Canada have been
working on various issues relating to these problems. We proposed a formal
approach to work ow modelling in [
        <xref ref-type="bibr" rid="ref21">21</xref>
        ] based on the Diagram Predicate Framework
(DPF) [
        <xref ref-type="bibr" rid="ref18">18</xref>
        ] which provides a formalism of (meta) modelling and model
transformations based on category theory and graph transformations ([
        <xref ref-type="bibr" rid="ref6">6</xref>
        ], [
        <xref ref-type="bibr" rid="ref8">8</xref>
        ], [
        <xref ref-type="bibr" rid="ref9">9</xref>
        ]).
We [
        <xref ref-type="bibr" rid="ref22">22</xref>
        ] extended the formal foundation of DPF to de ne (static) semantics for
timed and compensable work ow models and de ned the dynamic semantics of
models by a transition system where the states are instances and transitions are
applications of transformation rules. We developed a domain speci c language
to expedite work ow system development [
        <xref ref-type="bibr" rid="ref17">17</xref>
        ] and began the development of a
userfriendly interface to allow the health practitioner to determine the
correctness of behavioral properties of a healthcare work ow protocol [
        <xref ref-type="bibr" rid="ref20">20</xref>
        ]. We believe
that model driven engineering has the potential to develop complex systems
formally and can be used in healthcare domain.
2
      </p>
    </sec>
    <sec id="sec-2">
      <title>Modelling Healthcare Processes</title>
      <p>
        Clinicians generally follow clinical guidelines to manage speci c diseases. A
clinical guideline is a description of processes, treatment procedures, appropriate
medications, etc., to manage a particular disease. Interested readers may refer to
the guideline for Hypertension Management [
        <xref ref-type="bibr" rid="ref3">3</xref>
        ]. Clinical guidelines may be used
as basis for the formalization of healthcare processes as work ows. A work ow
model consists of tasks and the speci cation of the order in which they should be
executed. While performing a task, a user provides data to the system; typically,
this is lling out a standardized web-based form, a mobile app, or through the
use of some healthcare technology which provides automatic integration with
the appropriate healthcare datasource.
      </p>
      <p>
        For modeling healthcare processes, we have used the DERF work ow
language [
        <xref ref-type="bibr" rid="ref19 ref21">19,21</xref>
        ] which allows one to graphically model a work ow using the DPF
workbench [
        <xref ref-type="bibr" rid="ref14">14</xref>
        ]. Fig. 1 (a) (which is one level of the metamodelling hierarchy of
the DPF framework) shows the overall model of the Hypertension Management
Work ow [
        <xref ref-type="bibr" rid="ref3">3</xref>
        ]. We brie y review this work ow as we will refer to features of it
throughout this paper.
      </p>
      <p>Remark, there are some composite tasks such as `Visit1', `CBPM' (Clinical
Blood Pressure Measurement) in the work ow model; those are abstractions of
subwork ows. The subwork ow for `Visit1' composite task is shown in Fig. 1(b).</p>
      <p>Initially a patient's blood pressure (BP) is measured at the `Initial BP' Task,
which may cue the clinical hypertension management procedures if the BP is
greater than or equal to 140=90. If the initial BP is normal (&lt;= 140=90), the
work ow terminates. In Fig. 1 the patient's Hypertension is managed through
investigation and treatment. The clinical procedure (i.e., `Visit1', and other
subsequent tasks in Fig. 1) starts at the doctor's o ce. Patients with high BP have
risk of organ failures and/or other chronic illness. During the rst visit at the
doctor's o ce (`Visit1') BP is measured twice, an initial assessment is done, and
an investigation is started with diagnostic tests. After `Visit1' the work ow
executes `Ambulatory Blood Pressure Monitoring' (`ABPM') or `Self Home Blood
Pressure Monitoring (`SHBPM') if they are available and a \Clinical Blood
Pressure Measurement" (CBPM) is performed. Note the overall work ow model in
Fig. 1 uses the abbreviations CBPM, ABPM and SHBPM for these tasks.
Overall</p>
      <p>Safe</p>
      <p>Many healthcare processes involve numerous stakeholders with di erent
requirements. Frequently the user becomes a critical part of the healthcare
workow process whether it be the physician, a specialist or a lab technician, or
the patient, in situations where management of lifestyle parameters is a critical
component of the process. We are now researching a metamodelling approach to
work ows which incorporates the concepts of stakeholders and process
monitoring and provides userfriendly interfaces for a variety of users.</p>
      <p>
        The PhD thesis of [
        <xref ref-type="bibr" rid="ref5">5</xref>
        ] promoted a metamodelling approach to the
development of a framework for modelling care processes. There, Baarah presented
a UML-style metamodel for the care process monitoring application that had
3 main components: a process model, a performance model and an enterprise
model. The process model de nes the care process in terms of states to be
monitored, resources and rules that specify the transition from state to state as events
are received from the enterprise model. The performance model measures how
well the goals for the care process are being achieved in terms of metrics
computed from the monitored states, and events for the process. Alerts are de ned to
ag when targets are not being met. However, no automated implementation of
the metamodel was attempted, correctness of the process was investigated only
through the use of test scripts, and user interface issues were not considered.
      </p>
      <p>
        We extend the model Baarah presented in [
        <xref ref-type="bibr" rid="ref5">5</xref>
        ] to include users and user
interactions, allowing us to model user interaction as part of the process. Users
may interact with various tasks in the work ows, with the datasource, and with
the monitoring system (users typically receive alerts from the monitoring system
and acknowledge them, if required). This takes us from considering healthcare
work ows as an isolated entity to the more realistic modelling of a healthcare
systems.
3
      </p>
    </sec>
    <sec id="sec-3">
      <title>Metamodelling Healthcare Systems</title>
      <p>Given the complexity of the information requirements in healthcare systems, we
propose that separate metamodels, i.e., multi metamodels is the appropriate
approach to modelling healthcare systems. In this paper we discuss metamodelling
of ve aspects of healthcare systems: user access modelling, health process
modelling, modelling of process monitoring, user interface modelling, and modelling
of the data sources. Links (directed arcs) between the metamodels are used to
coordinate them (see Fig. 2), i.e., directed arcs from one metamodel to another in
Fig. 2 represent the bindings between metamodels. Using separate metamodels
for modeling di erent aspects of a system gives us the exibility for remodelling
and also makes models more readable. A user of a system may have access to
some tasks, views, and data; this requirement is modeled in Fig. 2 by means of
3 morphisms called `Task-acc', `View-acc', and `Data-acc'. A Task may trigger
some alerts (`Trigger' arc), may be displayed by a view (`Task-UI' arc), and may
read/write some data from/to the datasources (`Data-acc' arc). An alert is sent
to some users (`Send' arc) and is displayed by a view (`Alert-UI' arc). The user
interface of a system consist of some views; the user interface views access the
datasources and displays data (`Displays' arc) in di erent formats.</p>
      <p>Note that the work ow model in Fig. 1 is typed by the `Process metamodel';
moreover, there are some predicate constraints specifying the routing of the
work ow. The user access to a DERF work ow model (in Fig. 1) is de ned by
Predicate</p>
      <p>Visualization
[and_split] X</p>
      <p>Y
[and_split]</p>
      <p>Z
u2
M2
M1</p>
      <p>Copy-acc
the morphism called `Task-acc'. Here we discuss the metamodelling hierarchy
for the user model. The left hand side of Fig. 3 shows two modelling levels M2
and M1 of a user model where Su2 and Su1 are the speci cations (respectively).
The `Copy-acc' morphism is used to copy access from one user to another. One
instance of the `Copy-acc' morphism from `Doctor' to `Nurse' in Fig. 3 gives
Doctors all the access that Nurses have. The `Inrelation-with' morphism is used
to associate caregivers with patients. In this case, only doctors or nurses who
are treating a patient can access that patient's information. This access control
aspect is modeled using the `Inrelation-with' association. The right hand side of
Fig. 3 shows two modelling levels of a DERF work ow model with speci cations
Sw2 and Sw1 . At level M1 the predicate [and split] is used to model concurrency.</p>
      <p>To visualize the user access for a work ow model we propose a user interface
in Fig. 4 where the user nodes (e.g., Doctor, Nurse, Patient) are displayed at the
bottom of a work ow model. Selection of a user node from the bottom window
highlights all the accessible tasks from the work ow model. In the gure, the
user Patient has only access to the `SHBPM' that has been shown in gray. If a
doctor and a patient instance are both selected from the drop-down, the system
highlights all the tasks that this doctor can execute for this patient.</p>
      <p>While executing the `SHBPM' task the patient registers his lifestyle
information; in this work ow the patient is responsible for registering his lifestyle
information and doctors and nurses are responsible for the rest of the work ow.
Both the doctor and the patient should have access to the lifestyle information.
Doctors have a user interface similar to the one the patient uses, but it has many
more features (e.g., sending an e-mail to the lab for a lab test).</p>
      <p>Fig. 5 shows a model of work ow monitor having its own metamodelling
hierarchy and its association with a process metamodelling hierarchy and a user
access metamodelling hierarchy. Tasks from a DERF work ow model can trigger
alerts. We have two types of alerts: `Critical Alert', and one less urgent, called
`Reminder'. The `SHBPM' task from Fig. 1 triggers a `Data Entry' alert if the
patient forgets to enter data on some day. It also triggers a 'Excessive Weight
Overall</p>
      <p>
        Safe
Gain' alert if the patient's weight gain exceeds 10 pounds in less than 5 days. This
ring condition is encoded in the predicate [Cond 2] found on the co-ordinating
link between the `SHBPM' task and the `Data Entry' alert. Di erent users can
receive di erent alerts. In this gure, only the doctors are alerted about the
`Excessive Weight Gain' to indicate that the patient is retaining excessive uids
and the doctor should consult that patient immediately. The `Data Entry' alert
is sent to the patient to inform the patient that he or she has forgotten to enter
information. In a DERF work ow a task may have time constraints [
        <xref ref-type="bibr" rid="ref22">22</xref>
        ]. The
task `SHBPM' has a time constraint of `0 hour' delay and `24 hours' duration,
meaning the task `SHBPM' becomes enabled immediately after the execution of
the `O Clinic Measure' task and must be executed within 24 hours from when
it became enabled. [Cond 1] is a predicate that triggers the `Data Entry' alert
if 24 hours has elapsed and the `SHBPM' task is not executed. Discussion of the
`Dataource Metamodel' and the `UI-View Metamodel' are out of the scope of
this paper.
4
      </p>
    </sec>
    <sec id="sec-4">
      <title>User interfaces</title>
      <p>
        Successful of technology depends a great deal on usability or user-friendliness of
its user interface (also called \UI" or simply \interface"). A UI is the means by
which a person controls a software application or hardware device. A good user
interface provides a \userfriendly" experience (where userfriendly with respect
to software is de ned by the Merriam Webster dictionary as \easy to learn, use,
understand, or deal with") allowing the user to interact with the software or
hardware in a natural and intuitive way. In this section, we discuss the
development of two kinds of user interfaces needed for the Management of Hypertension.
(Some preliminary discussion of these interfaces may be found in [
        <xref ref-type="bibr" rid="ref16">16</xref>
        ].) The rst
is a user interface with various features intended for use by the clinician. The
second is a user interface, which we call a \Personal Health Monitor", intended
for use by the patient for self management of lifestyle attributes that cause the
patient to be at risk. Our goal was to provide both the patient and the clinician
with technology that can help in the management of the hypertension protocol,
but not to overwhelm them with tools that were not userfriendly.
      </p>
      <p>First, consider the interfaces which allow clinicians to interact with the
system. Fig. 6 shows 4 windows named `Work ow Viewer', `Task Execution Viewer',
`Lookup Viewer', and `NOVA Browser'. The right hand side of the `Work ow
Viewer' lists all tasks currently enabled by a work ow (e.g., Fig. 1) running
underneath the hood; and therefore are available to be done. Whenever a task
is executed, the task name is put on a calendar. Dates of scheduled
appointments are also presented on the calendar. By default the calendar shows the
'month view' but di erent levels of granularity may be con gured (e.g., weekly
view, hourly view, etc.). A task being executed is shown in the `Task Execution
Viewer'. Inputs required from the end user are shown in branches and the end
user must select a branch and assign a value to it through the `Lookup Viewer'.
The `Lookup Viewer' helps the end user to input information either by showing
relevant values from an ontology or by allowing the end user to enter
information. Once a task is executed, the information are hierarchically displayed in
the `NOVA Browser'. Fig. 6 shows that the user is executing the `Measure BP'
task. Inside the `Task Execution Viewer' window, the user provides input to
execute the task. This is an alternative way of taking user input rather than
using Forms. This view can also be con gured to include a traditional `Form
view' where the user provides input in `Form elds' (e.g., text boxes, drop down
boxes, etc.). While executing tasks the user has access to historical
information for this work ow instance; the intent here was to provide the user with a
more userfriendly environment to concentrate on care, avoiding the need to go
back through forms, either in a paper based or in an electronic format, to get
information they need.</p>
      <p>The `Lookup Viewer' at the bottom left of Fig. 6 provides options allowing
the user to select or enter data. This window is connected to a database and
shows only relavent data from the database. This view can also be con gured
to connect to an ontology and show relevant terminology from an ontology to
help the user input information while executing a task. Data inserted or selected
by the user in the `Lookup Viewer' is re ected in the `Task Execution Viewer'
window. When the user is nished entering all input for a task, the task is
executed and this updates `NOVA Browser' nodes. For this system we developed
di erent user interfaces for di erent user types. These are built depending on
the needs and expertise of the user.</p>
      <p>We now discuss the Personal health monitor smart phone application that
gives the patient a userfriendly interface for self management of lifestyle
attributes which cause the patient to be at risk. The patient can input data for
lifestyle attributes such as, exercise, smoking, intake of fruits and vegetables
and record such attributes as weight and blood pressure. The purpose of the
application is to assist patients keeping their health record such as blood
pressure record, body mass index, hours of exercise, dietary, etc. and monitor their
performance with their lifestyle target that was set by the physician from
`Hypertension management work ow'. The web-based tool allows both the patient and
the clinician to view summary data on lifestyle parameters between visits and
provide calendar views of past activities, future appointments, etc. In (Fig. 7)
we see that using the smart phone application, the patient can monitor their
exercise and eating behavior.</p>
      <p>The smart phone application allows the patient to execute the `SHBPM'
task (see `Overall' work ow from Fig. 1) from home. The `Personal health
monitor' application interacts with the `Hypertension management work ow'. The
integration is accomplished by the task `SHBPM' (see Fig. 1) from the
`Hypertension management work ow'. We have developed several interfaces that give
summary data to the patient and doctor by projecting patient's data into graphs
and charts. Fig. 8 shows two screenshots from the smart phone application that
takes blood pressure input from the patient and displays a graph of recent blood
pressure measurements. Projecting di erent data on the same timeline may
provide analytical ability to the user. The smart phone application can also fetch
an appointment date from the work ow and reminds a patient about the date
of the next visit.</p>
      <p>Demos of the system were made to several people including a local GP who
deals with many patients with chronic diseases, a nurse who is the VP of
Community Services for GASHA, our local health authority, and a physiotherapist,
who is the manager of the local Seniors' Wellness Program. The feedback on
the interfaces for the Personal health monitor was excellent { indeed the GP
is considering using some apps of this nature developed by our students in his
practice. The clinician views as shown in Fig. 6 were less enthusiastically
received. In general, it was felt that the clinicians would nd this tool too hard to
use; we plan to work with some clinicians and designers to see what can be done
to develop intuitive interfaces for clinical practice guidelines for chronic diseases
suitable for use by clinicians.</p>
    </sec>
    <sec id="sec-5">
      <title>Conclusion</title>
      <p>
        Modelling the ow of tasks outlined in a clinical guideline, even a complex one, is
not too di cult if done in consultation with a domain expert (clinician familiar
with the procedure). Our modelling tools allow us to deal with the overview rst
and `zoom in' to re ne tasks into sub work ows. One challenge is to recognize
that guidelines are not rigidly de ned processes. They involve many exceptional
situations, and the sequence of tasks described by a guideline may need to be
altered, during the enactment of a work ow for a particular patient, in order
to meet user needs, while maintaining guideline intentions as much as possible
[
        <xref ref-type="bibr" rid="ref15">15</xref>
        ]. Much of this may be dealt using \decision points" in the guideline, where
several choices are available, and the choice is left to the physician (sometimes
in consultation with the patient, and using background information contained
in an ontology or other datasource). In other situations the physician may need
to override the execution of the work ow due to a circumstance or exception
not covered by the guideline. Allowing the clinician to simply skip part of the
work ow (while providing a reason to explain why) is not di cult, but in
general dealing with exceptions not covered in the guidelines is a real challenge to
work ow modelling.
      </p>
      <p>In previous work, we looked simply at modelling the ow of tasks in a
healthcare process; however, conceptualizing a healthcare system as being comprised
of ve metamodels allows us to more realistically model these complex systems.
While incorporating stakeholders and monitors in the MDSE paradigm is highly
innovative, these features are essential if software systems are to automatically
perform the kinds of tasks users are increasingly demanding. We believe that
the metamodelling together with MDSE principles in general can be used as the
main methodology in the development process of software for care processes. By
separating di erent concerns of a system into several metamodels we get more
exibility allowing us to modify one aspect of a system described by a particular
metamodel without a ecting other metamodels. We remark that this is early
work in our attempt to model a systems as complex as the healthcare system;
we need more e ort to capture the complexities of real-life systems. We have a
prototype implementation for part of the system using the DPF framework, and
we are working to extend it.</p>
    </sec>
    <sec id="sec-6">
      <title>Acknowledgement</title>
      <p>MacCaull would like to thank Natural Sciences and Engineering Research
Council of Canada, and Lamo acknowledges support from the St. Francis Xavier Heaps
Chair in Computer Science. We are greatful to the StFX undergraduate student,
Miao Huang for his contributions to the Hypertension Work ow Model and to
Jane Newlands, Manager of the Seniors Health Wellness Program for GASHA,
a health authority in Nova Scotia for providing valuable feedback to us.</p>
    </sec>
  </body>
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