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  <front>
    <journal-meta />
    <article-meta>
      <title-group>
        <article-title>Analysing the Electrical Patient Recruiting Agent system using the WIT trinity</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <string-name>Tina Balke</string-name>
          <email>t.balke@surrey.ac.uk</email>
          <xref ref-type="aff" rid="aff3">3</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Samhar Mahmood</string-name>
          <email>samhar.mahmoud@kcl.ac.uk</email>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Martin Neumann</string-name>
          <email>maneumann@uni-koblenz.de</email>
          <xref ref-type="aff" rid="aff2">2</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Harko Verhagen</string-name>
          <email>verhagen@dsv.su.se</email>
          <xref ref-type="aff" rid="aff1">1</xref>
        </contrib>
        <aff id="aff0">
          <label>0</label>
          <institution>Kings College London</institution>
          ,
          <country country="UK">UK</country>
        </aff>
        <aff id="aff1">
          <label>1</label>
          <institution>Stockholm University</institution>
          ,
          <country country="SE">Sweden</country>
        </aff>
        <aff id="aff2">
          <label>2</label>
          <institution>University of Koblenz Landau</institution>
          ,
          <country country="DE">Germany</country>
        </aff>
        <aff id="aff3">
          <label>3</label>
          <institution>University of Surrey</institution>
          ,
          <country country="UK">UK</country>
        </aff>
      </contrib-group>
      <abstract>
        <p>In [5] a conceptual model is proposed for a new type of systems named Artificial SocioCognitive Systems (ASCS). In this paper we use the multiagent system described in [2] as an instance of an ASCS and deconstruct the system using the conceptual model of the so-called WIT-trinity. After the deconstruction we discuss the potential use the WIT could have had in the design phase of the system and outline potential for future development. First we will briefly describe the ASCS and ePCRN-Idea. View 1: The world system, W, as the agents (both human and artificial) see it and relate to it. View 2: An ideal institutional system, I, that stipulates the way the system should behave. View 3: The technological artefacts, T , that implement the ideal system and run the applications that enable users to accomplish collective actions in the real world according to the rules set out in I.</p>
      </abstract>
    </article-meta>
  </front>
  <body>
    <sec id="sec-1">
      <title>Introduction</title>
      <p>
        As described in [
        <xref ref-type="bibr" rid="ref5">5</xref>
        ] ASCS are systems in which it is possible to govern the interaction
of agents that are situated in a physical or artificial world by means of technological
artefacts. The key element in this description is in the “governance” part that mediates
between the world and the technological artefacts. It is an aspect worth distinguishing
in ACSC because of the need to control the activity of complex individuals that are at
the root of ASCS. The governance forms the institutional part of the system. In order to
elucidate how such governance is achieved [
        <xref ref-type="bibr" rid="ref5">5</xref>
        ] propose the following tripartite view of
ASCS:
      </p>
      <p>
        These three views are interrelated through three binary relationships (as depicted
in Fig. 1). The institutional world corresponds with the real world by what is known
as a “counts-as” relationship [
        <xref ref-type="bibr" rid="ref1 ref6">6, 1</xref>
        ] by which (brute) facts and (brute) actions in the real
world correspond to institutional facts and actions in the institutional world I only when
these comply with the institutional conventions, in which case the institutional effects of
those institutional actions carry over to have effects in the real world. Note that W is not
the entire real-world, only that part of the world that affects and may be affected by the
system. Secondly, the conventions and norms prescribed in the institutional world have
their counterpart in the technological world in the sense that institutional conventions
constitute a specification of the requirements of the system that is implemented in T .
In turn, the system, as implemented in T is what enables interactions (through a proper
interface) in W . Thus, the agents in W control the artefacts in T , but also, we contend,
this relationship is symmetric, in that by virtue of the percepts delivered via T , the
artefacts in T effect some control over the agents in W . It should be noted that each of
these three binary relationships needs to satisfy certain integrity conditions:
– The corresponds relationship needs: (i) to guarantee that the objects and concepts
involved in the descriptions and functioning in I are properly associated with
entities in W ; i.e., that there is a bijection between terms in the languages in I and
objects and actions in W . (ii) that the identity of agents in W is properly reflected
in their counterparts in I and is preserved as long as the agents are active in the
system, (iii) that the agents that participate in W have the proper entitlements to be
subject to the conventions that regulate their interactions and in particular to fulfil
in W those commitments that they establish in I, and (iv) that the commitments
that are established according to I are properly reflected in W .
– The implements relationship needs to be a faithful programming of the institutional
conventions so that actions and effects are well programmed, norms are properly
represented and enforced, etc.
– Finally, the controls relationship needs to make sure that: (i) the technological
artefacts work properly (communication is not scrambled, data bases are not corrupted,
etc.) and (ii) inputs and outputs are properly presented and captured in W,
according to the implementation of the corresponding processes in I. (iii) Algorithms and
data structures in T behave as the conventions in I prescribe.
3
      </p>
    </sec>
    <sec id="sec-2">
      <title>Case Study: ePCRN-Idea</title>
      <p>In the following we present specific case study how disentangling socio-technological
artefacts in the line of this integrated view - rather than an isolated analysis of the
individual e.g. technological or social dimensions - enables a systematic comprehension of
the recursive dependencies and influences of these different dimensions on each other.</p>
      <p>
        Clinical trials are the gold standard by which the efficiency of medical interventions
are evaluated. They involve the controlled testing of treatments on patients who match
certain criteria, e.g. age, gender, condition. The stringent nature of these criteria,
however, mean that many trials are unsuccessful in recruiting sufficient patients. A review
of the UK Medical Research Council found that only 31% of trials actually recruited
to their planned target, with 30–40% of costs arising during the recruitment phase
alone [
        <xref ref-type="bibr" rid="ref3">3</xref>
        ], as discovering and contacting eligible potential recruits is logistically and
legally challenging. Consequently, many research projects take far longer to complete
than is desirable (or, in the worst case, not at all). ePCRN-IDEA [
        <xref ref-type="bibr" rid="ref2">2</xref>
        ] is a human-driven
agent-based recruitment system for clinical trials. Figure 2 illustrates the architecture of
the overall system, where arrows indicate the interactions between agents, i.e. the flow
of information. To provide greater insight, the links are also annotated with example
operations that occur through these interactions. Note that these are just examples and
do not provide an exhaustive set of interactions.
      </p>
      <p>The process of trial recruitment begins with the Trial Designer Agent. This is an
agent that resides within the organisation of the researcher. The researcher is a human
operator responsible for defining new trials. The Trial Designer Agent works with the
researcher to generate an instantiation of the clinical trial model. The Trial Designer
Agent then passes the newly created trial model to one or more Trial Manager Agent.
Many of these exist throughout the healthcare system available in the country; typically,
these would be distributed in a geographical sense. In the UK, for example, healthcare
is split between multiple geographical management groups termed primary care trusts
(each would have one agent). The Trial Manager Agents are responsible for
coordinating in which clinics recruitment should be performed (for each trial). Once they have
decided this, they pass the new trial model to a set of Trial Recruiter Agents. These
exist on every GP’s computer in every clinic. The Trial Recruiter Agent monitors the
data entry by the GP to decide if any patient matches the eligibility criteria for the trials
it is aware of. If a match is observed, the Trial Recruiter Agent generates a graphical
pop-up asking the GP to recruit the patient. Obviously, this requires real-time access
to patient information, which is provided by a Patient Data Handler Agent. This also
(1) Creates
a trial
Researcher
(9) Provides
trial feedback</p>
      <p>Trial
Designer</p>
      <p>Agent
Provides feedback</p>
      <p>Trial
Conductor</p>
      <p>Agent
(2) Injects trial
into system</p>
      <p>Trial
Manager</p>
      <p>Agent
(8) Informs of
recruitment
(3) Passes trial
to selected
clinics</p>
      <p>Patient Data</p>
      <p>Handler
Agent</p>
      <p>GP’s Clinic
(5) Provides
patient data
(4) Inputs
patient data
(6) Pop-up!</p>
      <p>Trial
Recruiter</p>
      <p>Agent</p>
      <p>Patient</p>
      <p>X (p7a)tiAesnkts</p>
      <p>General
Practitioner
sits on the GP’s computer, but is owned and managed by the company that controls
the patient’s medical records.5 Once someone has been recruited, an Trial Conductor
Agent is contacted to initiate the trial with the patient. In the simplest case, this might
involve retrieving information (e.g. a blood pressure reading), whereas in other cases it
could involve complex interventions (e.g. drug treatments) accompanied by proactive
data collection. The system has been installed in more than 50 clinics with more than
120 clinicians involved. We have been successful in initiating three (diverse) clinical
trials within the system, with 811 patients being recruited for these trials, exceeding
normal recruitment figures.
4</p>
    </sec>
    <sec id="sec-3">
      <title>Mapping the Case Study to the W-I-T Dimensions:</title>
      <p>Along the lines of the tripartite view of ASCS the case can be disentangled along the
views of the world W , institutions I and technological artefacts T . W , i.e. the world
view, is represented by several of the components of our case study. This includes the
humans in the system such as the GP, the patient and the researcher. Likewise, the office
or entity executing the actual clinical trials is part of the real world.</p>
      <p>The digital entities enabling the recruitment process are part of the technical view.
This dimension includes the two software agents (Trial Managing Agent, Recruitment
Agent) as well as the patient data handling system.</p>
      <p>The design agent is not part of the technical dimension, but is considered
belonging to the institutional dimension of WIT. The reason for this categorization is that the
research design constitutes an institutional fact of scientific practice. Another
institution can be found when considering the doctor patient relationship (marked as x in the
diagram) that is an institutional in the sense that is follows a standardize pattern of
conduction by both parties involved. This particular institution is affected by the
implementation of the system, both in terms of a change of routines of interaction (additional
5 In the UK, several commercial vendors provide Electronic Health Record databases that
perform this function. Clinics are largely free to select their preferred one.
questions from the GP to the patient which need to be asked during the appointment)
as well as well utilization of new technology for storing and communicating
information. A final institution we identify in the case study is the GP practice itself, whose
organizational structure and processes are reorganized by the information.</p>
      <p>Concerning the controls relation between Wand T , the condition (i) that the
technological artefact works properly is satisfied need to be shown for the trial managing
agent, the recruitment agent and the patient data handling system. Correct functioning
of the trial managing agent is secured by the trial designer agent, who provides input
and controls the output of the system. Controlling the output secures that system
functions as intended. The recruitment agent is controlled by the trial conductor, whereas
the patient data handler is under control of the GP. Moreover, it is obvious that in the
initial phase of implementing a technological system bugs may occur in every
technological system. In such case it is important that people (in W) handling the system
can communicate with the systems engineer. Thus the design of relations within Wis
essential for a proper relation between Wand T .</p>
      <p>Condition (ii) that the input and output is properly presented is decided ultimately
by the question whether the system is factually used by the GP in everyday practice.
Here ease of using, design of the user interface and the time needed to get acquainted
with the system and how much time it occupies in the practical use. The same holds for
the patient data handler. However, this is a more established system.</p>
      <p>Condition (iii) that T behaves according to the standard in Ineed to be secured by
the software engineer developing the system. The primary focus to increase success and
speed of clinical trials is ultimately derived from the standards of medical ethics to save
human life and the fact that clinical trials are the gold standard to achieve the goal of
medical progress which in turn contributes to achieve the goal of medical ethics.</p>
      <p>However, condition (iii) of the controls relation is constraint by several sometimes
contradictory norms and institutions which are specified in the implements relation
between T and I. This concerns issues such as protection of private data, time schedule
of the GP necessary for an effective doctor-patient relation, or trial priorities. Many of
the issues cannot be answered by yes or no. However, at least data protection needs to
be secured by the technological implementation and it need to be secured that the trial
recruiter agent produces a proper match between the trial and patient characteristics.
For this purpose it is essential that the access to patient data works properly, i.e. that the
recruiter agent selects all or as much as possible eligible patients but only those, and at
the same time fulfils the condition of protection of private data.</p>
      <p>To investigate whether the corresponds relation between Wand I is satisfied, it
need to be shown that the conditions (i) (iv) are fulfilled. Concerning (i), a bijection
between Wand Ineed to be demonstrated. For instance, it needs to be shown that the
trial manager agents are geographically distributed in the world to sufficiently cover
e.g. the whole UK and sufficiently coordinate the allocations of patients to trials. This
proves that the goal of the system, which is ultimately derived from I, is factually
realized in W. Likewise if a successful implementation of the system reduces costs for
recruitment will realize the institution of economic optimization.</p>
      <p>Condition (ii) that identity of Wis preserved while agents are active in the system
concerns correct handling of patient data. The test runs indicate that this is the case.</p>
      <p>Examining condition (iii), in particular the entitlements of the patient are highly
sensitive. Primarily the GP is responsible that these entitlements are respected, i.e. that
the well-being and the privacy of the patient is guaranteed.</p>
      <p>Concerning condition (iv) that commitments from Iare properly reflected in Win
particular the GP and the researcher have to be considered. It can be stated that the
technological system supports the commitment of the researcher. Prime goal of the system
is to increase efficiency of research, i.e. to encourage the commitment of the researcher
to the institutional goal of scientific progress. This has to be realized given the constraint
to respect the commitment of the GP to factually realize in Wthe commitment to the
institutional standards for doctor-patient relationships. Thus it needs to be investigated
whether the system saves time for the consulting dialogue or whether further time gets
lost.
5</p>
    </sec>
    <sec id="sec-4">
      <title>Discussion</title>
      <p>Certainly the overall objective of the information system utilised as case study is the
optimisation of clinical trials. However, perceiving it in the context of the tripartite
view of ASCS allows disentangling the recursive interrelations in which such an
information system is placed when put into practice rather than optimising GP practice,
clinical research, or the technological performance of the systems in isolation. We have
classified entities, one arrow and all boxes of the case study. It has to be noted that
institutions were in basically all elements, but normally not explicit. While far from
being comprehensive, this first analysis provides a test case to study the two recursively
related questions of (i) how the tripartite view of ASCS gives advice to system design
and refinement from the perspective of the physical world and institutional facts and
(ii) how the implementation of the system in the environment of the physical world and
institutional facts gives rise to changes of this environment. For instance, the effect on
the institutional setting of GP practice (additional questions to ask in the doctor patient
relations) might have an effect on the acceptance and performance of the system as
well as the system might have an effect on the effectiveness of the doctor patient
relations and acceptance of this institution from the side of the patient. On the other hand,
if it becomes an institution that the patient gets a ’feeling’ of being involved in a
research community might have an effect on the effectiveness and acceptance of clinical
research.</p>
      <p>The ePCRN-Idea system has many institutions governing the interaction among the
various actors of the system, as well as governing the acting that such actors can take
with regards to resources accessible to them. For example, patient data is a very
sensitive type of information that requires extra security measurement when being
communicated. For such reason, patient data in the system under analysis is always kept
inside GPs’ clinics (marked as a red box in Fig 2). Another example of an institution
is the constraint that the manager agent impose on the recruiter agent in that the latter
is obliged to follow the trials priorities imposed by the former when selecting the trial
to inform a particular GP of. These institutions and many more are considered in the
original system design but are kept implicit. Once they are separated into a separate
entity, they become clearer and easier to reason about and modify.</p>
      <p>Also, by separating users of the system from the technology that enable system
usability, we can clearly observe the implication that each part have on the other part.
Based on the result of the deployment of the system, we can clearly observe that the
used technology has helped increasing the number of recruited patient for clinical trial.
This can be seen as a very positive effect on the world achieved through the technology.
However, consultation between GPs and patients are usually short and highly
demanding. So, adding the extra task of recruiting the patient during consultation makes it even
more stressful. This has an implication that the technology needs to have a very
minimal time demands. The technology also need to be efficient, which may be achieved by
learning the model of GPs behaviour and interest, so only notify them once they have
extra time and only about trials that they are interested in.</p>
    </sec>
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