=Paper=
{{Paper
|id=None
|storemode=property
|title=Model-based Integration of Clinical Practice Guidelines in Clinical Pathways
|pdfUrl=https://ceur-ws.org/Vol-863/paper7.pdf
|volume=Vol-863
|dblpUrl=https://dblp.org/rec/conf/caise/Heiden12
}}
==Model-based Integration of Clinical Practice Guidelines in Clinical Pathways==
https://ceur-ws.org/Vol-863/paper7.pdf
Model-based Integration of Clinical Practice
Guidelines in Clinical Pathways
Katja Heiden
University of Applied Sciences and Arts, Faculty of Medical Informatics,
Emil-Figge-Straße 42, 44227 Dortmund, Germany
katja.gippert@fh-dortmund.de
Supervised by Professor Dr. Jakob Rehof
Abstract. Healthcare providers are facing an enormous cost pressure
and a scarcity of resources, so that they need to realign in the tension
between economic efficiency and demand-oriented healthcare. Clinical
Practice Guidelines (CPGs) and clinical pathways have been established
to improve the quality of care and to reduce costs at the same time.
CPGs have a positive impact on the health outcome. However, their in-
fluence on the clinical routine is still very low due to their narrative and
non-formalized form. This paper presents a model-based approach, how
CPGs can be operationalized by transforming the CPGs in clinical path-
ways and therefore translate the abstract recommendations in concrete
process flows. A metamodel will be developed to represent guideline-
compliant pathways and to support the users in the derivation process
by information technology.
Keywords: Clinical Practice Guidelines, Clinical Pathways, Business
Process Management, Metamodel, Health Level 7
1 Introduction
Clinical practice guidelines (CPGs) and clinical pathways have been established
as instruments for the quality assurance and process optimization in the health-
care domain. Both concepts define a standardized best practice for a specific
disease. CPGs are defined as ”systematically developed statements to assist prac-
titioner and patient decisions about appropriate health care for specific clinical
circumstances” [4]. CPGs provide evident medical knowledge for diagnostic and
therapeutic issues and contain aggregated information for one specific medical
indication. The European Pathway Association (E-P-A) defines a clinical path-
way as ”a complex intervention for the mutual decision making and organisation
of care processes for a well-defined group of patients during a well-defined pe-
riod” [21]. In addition, the E-P-A indicates several characteristics, which should
be considered by clinical pathways; e.g. ”the coordination of the care process by
coordinating the roles and sequencing the activities of the multidisciplinary care
team, patients and their relatives” [21]. Thus, clinical pathways can be seen as
a road map of patient management.
2 Katja Heiden
The positive impact of clinical practice guidelines on the quality of care has been
scientifically proven in Grimshaw et al. [5]. However, their influence on patient
care in Germany is still very low [15]. A decisive factor for the success of CPGs
is the provision of the knowledge at the point of care [10]. The guideline rec-
ommendations are abstract and therefore not directly applicable. Thus, these
recommendations have to be implemented and tailored to local settings. Clin-
ical pathways are appropriate for that purpose; they can adapt the content of
clinical guidelines in form of concrete process flows [10]. That way, the latest
scientific findings can be applied in everyday healthcare and therefore lead to a
best quality of patient care [17].
1.1 Significant Problems
The consideration of CPGs during pathway development is highly recommended,
but there are no standardized mechanisms, which ensure a guideline-compliant
care. The research of pertinent CPGs, the extraction of the relevant medical
knowledge and the integration of these recommendations in the pathway devel-
opment process is very time-consuming and resource-intensive. A further prob-
lem in this context is the publication of CPGs in narrative form, e.g. as text or
hypertext documents [10]. Thus, they are not directly applicable. The first step
towards a computer-based process support is the formalization of the guideline
content [10]. This translation is burdensome, because the narrative guidelines
needs to be mapped onto coded data. Therefore, domain knowledge is required
as well as knowledge about the target language to describe the CPG.
The definition of the pathways is done by domain experts. For this purpose, an
interdisciplinary team is built composed of all professional groups involved, e.g.
physicians, nurses, medical controllers, quality assurance representatives. The re-
sults of the development process are text documents or informal process models,
which describe the clinical pathway. Thus, they cannot directly be interpreted
by IT-systems; a formal logic is needed and additional technical information for
the enactment of the pathways needs to be defined, e.g., mapping of service calls
or forms to specific tasks. The implementation of clinical pathways is a separate
step, which is performed by IT-specialists. It is an error-prone task, because
these experts often do not have detailed domain knowledge and sometimes the
pathway definitions are ambiguous. There is a high need for communication be-
tween the domain- and the IT-specialists [16]. Several cycles are necessary to
implement the pathways in the information systems. Thus, a gap between devel-
opment and implementation of clinical pathways exists as well as a media break
between both process steps.
The CPGs offer a lot of additional information, which are not directly relevant for
the control flow of the patient treatment. For example, complications or guiding
symptoms of a disease are pointed out. This information is often not consid-
ered in the pathway development process, although it would mean an increase
of information during patient care. Clinical pathways are used for training and
education purposes, where they represent reliable action guidelines especially
Model-based Integration of Clinical Practice Guidelines in Clinical Pathways 3
for young professionals. The additional information from the CPGs could create
added values and should be integrated in pathway models.
1.2 Research Questions and Objectives
To adress the problems mentioned in Sect. 1.1, the main research question is
”how clinical pathways can be derived from clinical practice guidelines and how
the interdisciplinary team can be supported in the translation process by infor-
mation technology”.
Therefore, a model-based integration of CPGs in the clinical pathways should be
realized and a metamodel is being developed to describe evidence-based path-
ways1 . Structures and elements of both concepts are merged to one generic
model. This approach supports the entire process and life-cycle of clinical path-
ways by one metamodel.
The research objectives are:
1. Development of a concept describing the derivation process of clinical path-
ways from CPGs
2. Collecting all pertinent information pieces and translate them into compo-
nents of a generic metamodel
3. Implementation of an editor to support the domain experts in the derivation
process
4. Development of algorithms, which translate the clinical pathways described
by the metamodel into the target language of a specific system
5. Evaluation of the results in a concrete setting2
2 Related work
Different methological approaches exist to implement guideline recommendations
in the operational practice. Those show considerable differences concerning the
aim or result of the translation process (defining clinical pathways or creating
alerts and reminders in form of computer-interpretable guidelines). Additionally,
they vary in the degree of automation (highly manual vs. semi-automated ap-
proaches):
One approach is to formalize the content of the CPGs by the help of guideline
representation languages (see [9, 19]). The narrative CPGs are translated in a
computer-interpretable form, which can be processed in decision support sys-
tems. It is cumbersome and error-prone to map prose text to coded data [10],
because CPGs can partly be ambiguous, incomplete, and even inconsistent [12].
Several guideline representation languages exist, which differ in the degree of
formalization; task network models, which formally represent medical guidelines
1
The term evidence-based pathway should illustrate that the metamodel combines
characteristic information of the evident CPGs and the clinical pathways (see [8]).
2
This is done in a cooperation with a German hospital.
4 Katja Heiden
and medical knowledge (e.g. GLIF [2], Asbru [13], PROforma [20]) or XML rep-
resentations for structuring guideline documents (e.g. GEM [18]). If computer-
interpretable guidelines (CIGs) should be used by a hospital in order to provide
the medical knowledge in everyday healthcare, the hospital information systems
(HIS) need to have the ability to interpret and use those formalizations. The
result of this translation process is not a clinical pathway by definition; rather
computer-interpretable guidelines are created, which support the decision mak-
ing process during the patient treatment. It provides one way to implement
guidelines in daily routine, but, according to [10], the translation of CPGs into
alerts and reminders does not support the patient treatment as a unit.
The second approach is a highly manual process, where clinical pathways are de-
veloped on the basis of related CPGs (see [1, 6, 14]). The pathway development
process starts with an extensive literature research, where pertinent CPGs for
the clinical pathway can be identified. This analysis needs to be done manually
by the interdisciplinary team. In some hospitals even a special group is built to
perform this time-consuming task. The recommendations from the CPGs can
be used as an input for the pathway development. The content of the medi-
cal guidelines needs to be tailored to local conditions and therefore a consensus
among the participating health professionals needs to be reached [10]. Informa-
tion technology is mainly used for modeling tasks. The result of this development
process is a clinical pathway for one specific healthcare facility. Additionally, it
is an informal or even a paper-based description, which needs to be implemented
in the IT-system of the institution. This approach is very time-consuming and
resource-intensive. Information technology is not used for the whole life-cycle
management of clinical pathways.
The last approach focuses the systematic derivation of clinical pathways from
CPGs by the help of a model-based methodology (see [3, 8]). Jacobs et al. [8]
developed a reference model for the methodical transfer of CPGs in clinical
pathways. The reference model was exemplary deduced from the breast cancer
treatment. Jacobs et al. try to derive an universal pathway for one CPG, which
can be adapted to a special institution in a further step. Schlieter et al. used the
results from Jacobs et al. and carried them forward. They chose a different rep-
resentation language for the modeling of clinical pathways. They added rule sets
to the reference model in order to define the adaption and extension of specific
models. That way they offer a description how to use the formalized CPG in an
institution. Both approaches only use the clinical algorithms to derivate clinical
pathways and to link both concepts; additional information of the CPGs are not
employed.
3 Proposed Solution and Preliminary Result
We propose a model-based approach for deriving clinical pathways from CPGs
(Fig. 1 shows the main steps of this process).
The first step is done by the domain experts. They design a clinical pathway by
considering the recommendation from the CPG and by adding additional infor-
Model-based Integration of Clinical Practice Guidelines in Clinical Pathways 5
mation, which cannot be found in CPGs, e.g. resources, responsibilities, costs,
nursing care. The experts are supported by an interactive editor, which facili-
tates the extraction of pertinent information from the CPGs and which provides
functions to record further information. The second step has to be prepared
by IT-specialists. Every clinical pathway is described through the metamodel.
In order to use the clinical pathways in different HIS or Workflow Management
Systems (WFMS), they need to be transferred in the target language of a specific
system (mapping process). This is the precondition for the translation process,
which generates the formalism of the target system. Thus, the metamodel has
two key tasks; it provides a formalized representation and a vendor independent
description of evident pathways. The whole life-cycle management of clinical
pathways is taken into account.
Fig. 1. Proposed Solution
3.1 Conceptual Comparison
For the purpose of deriving clinical pathways from CPGs, we firstly compared
both concepts based on the following criteria: 1. representation; 2. structure;
3. content; 4. key users; 5. development; 6. dissemination; 7. implementation;
8. standardization; 9. quality improvement; 10. cost effectiveness; and 11. liabil-
ity. We performed a detailed literature research to point out the differences and
similarities. Tab. 1 summarizes our findings and outlines the main aspects. These
findings are further used to define the derivation process. The comparison points
out, which information can be extracted from the CPGs, which information has
6 Katja Heiden
to be added by the users to describe clinical pathways, which community func-
tions needs to be provided by the editor to support the development process and
how the information extraction from the CPGs might be realized.
Table 1. Comparison between CPGs and clinical pathways
CPGs Clinical Pathways
1. arbitrary; prose; tables; clinical paper-based pathways: comparable to
algorithms CPG representation; eletronic
pathways: formalized; process-oriented
2. no binding agreement; very different clinical pathway; sub processes;
elements; attributes; values
3. abstract recommendations; statements medical and nursing activities;
for diagnostic and therapeutic issues; resources; responsibilities; timeline;
additional information; strength of costs; treatment goals; inclusion and
evidence; quality indicators exclusion criteria
4. physicians; patients; insurance providers physicians; controlling; patients
5. initiative of the physicians; national, initiative of the health organization;
regional and local developments; cyclic local development; interdisciplinary
process; systematic approach team; cyclic process
6. passive dissemination; electronic and active dissemination
paper-based media
7. combining different implementation implementation is done by IT-experts;
strategies; the most effective strategy: integration in the HIS creates the most
integration in IT-systems added values
8. reduction of variances; standardization standardized treatment; coordination of
of the decision making process responsibilities; unification of the
documentation; elimination of variances
9. best practice; evident knowledge; quality improvement of the processes,
consensus among experts; reliable data structures, outcomes; improvement of
education purposes; controlling
10. benefit-cost analysis; elimination of reduction of average length of stay;
ineffective, outdated and cost-intensive resource-efficient treatment;
procedures transparency of the treatment costs
11. legally non-binding legally non-binding; deviations must be
documented (variance documentation)
3.2 Development of the Metamodel
CPGs and clinical pathways show considerable differences (see Sect. 3.1). Thus, a
metamodel is required, which provides a formalized reflection of evidence-based
pathways. We used different sources of information to gather pertinent elements
for the metamodel (see Sect. 4). The identified components were transferred into
a preliminary metamodel. The elements can be classified into five categories, (1)
descriptive elements to represent guideline information, e.g. title, validity range,
Model-based Integration of Clinical Practice Guidelines in Clinical Pathways 7
(2) structural components, e.g. phases and stages of the treatment process, (3)
constructs for the definition of the control flow, e.g. branches, synchronizations,
decision steps, (4) components to describe the activities, e.g. medical and nursing
activities, and (5) components to define responsibilities, e.g. competences and
resources. Additionally, there are information, which cannot be directly mapped
to any of the five categories. The CPGs provide a lot of unstructured additional
information, e.g. epidemiological facts, causes, risk factors, or complications.
Those information will be represented by a generic parameter system in order
to find a consistent description of this information.
The selection of an appropriate representation for the metamodel was done by
the evaluation of three guideline representation languages, namely Asbru [13],
GLIF [2], GEM [18]. Additionally the Health Level 7 Care Plan Model3 [7] was
taken as a reference. We analysed, which language or model can depict most
of the elements. None of them can describe all components of the metamodel;
the guideline representation languages do not provide elements e.g. to describe
responsibilities or resources. The HL7 Care Plan Model does not provide all re-
quired elements to describe the guideline information, e.g., strength of evidence.
Tab. 2 shows the results of the analysis. It outlines the quantity, how many ele-
ments of the metamodel can be depicted (X), partly depicted ((X)), and which
components cannot be described (-) by the representation language.
Table 2. Analysis of the representation languages
X (X) -
Asbru 11 8 10
GLIF 12 8 9
GEM 9 7 13
HL7 Care Plan Model 19 1 9
The HL7 Care Plan Model is the most feasible approach to represent the
metamodel. It is not a normative standard yet; rather it is a draft, which is
steadily being refined [7]. As a consequence, it can be used as a basis and new
RIM4 -compliant artifacts can be added to represent the remaining elements. In
addition, the HL7 standard is accepted worldwide and it ensures that individual
solutions for specific target systems and proprietary formats can be avoided. The
HL7 Care Plan Model was extended by defining the following RIM-compliant
elements, which are not provided by the original model:
1. assignment of CPGs to a clinical pathway (evident basis)
3
HL7 provides standards for interoperability that improve care delivery, optimize
workflow, reduce ambiguity and enhance knowledge transfer among all of the stake-
holders in the healthcare domain (see [7]). The HL7 Care Plan Model can be used
to define action plans for various clinical pictures.
4
HL7 version 3 information models are derived from the Reference Information Model
(RIM), which is an information model for health care data.
8 Katja Heiden
2. structural components to define intersectoral pathways as mentioned in the
CPGs; mapping of different clinical pathways to one specific treatment phase,
e.g. diagnostic and therapeutic care, follow-up, rehabilitation
3. specification of costs, strength of evidence and recommendation, etc.
4. defining the detailed control flow (integrating the HL7 Workflow Control
Suite of Attributes)
5. providing additional information, which are pointed out in CPGs; e.g. com-
plications, and guiding symptoms
3.3 Derivation Process
The conception of the derivation process is still being defined. The findings
from the comparison between the CPGs and clinical pathways (see Sect. 3.1)
already show, that the translation is a semi-automated process, which will be
completed by decisions and interactions of the interdisciplinary team. The main
requirements for the editor can be defined based on the present results:
1. Model component (a clinical pathway should be derived gradually based on
a CPG; functions for the information extraction and recording of additional
information are as well provided as functions to support the division of labor,
e.g. version control, groupware functions, reviews)
2. Translation component (it is a multi-level process to translate the evident
pathways into the formalism of the target system; the technical definition of
the mapping between the elements of the metamodel and the target system
is done here)
There will be some challenges to meet concerning the creation of concrete path
models, e.g. how to deal with the information, which cannot directly mapped to
an element of the target system?; can the additional information create added
values for the users?; how can they be displayed e.g. by a wiki, which can be
perceived on demand (f.i. by young professionals)?
A detailed requirements analysis will be done in cooperation with a German
hospital, where the local development process will be investigated.
4 Research Methodology
In order to investigate the main research question mentioned in Sect. 1.2, we
conducted a detailed literature review of related approaches, which focus on
the automated or partly automated translation of CPGs in clinical pathways
(see [8, 9, 17, 19]). We gathered information about remaining problems in that
research area and specified them by consulting an experienced process manager
and path designer. That way, a problem-solving approach could be investigated
based on the findings of the literature review and the practical evaluation in a
healthcare facility.
Components for the metamodel were gathered through the analysis of guideline
Model-based Integration of Clinical Practice Guidelines in Clinical Pathways 9
representation languages (GEM [19], GLIF [2], Asbru [13]), existing CPGs5 ,
clinical pathways and path modules6 . Thus, characteristic information of both
concepts could be collected and transferred to a preliminary metamodel. The
analysis of existing languages and models substantiate the hypothesis, that there
is no language or model, which can merge the information contained in the CPGs
and the clinical pathways.
The resulting system prototype will be evaluated in a concrete local setting.
5 Expected Contributions
This model-based approach supports hospitals or other healthcare facilities in
considering the CPGs during the pathway development process and therefore
in transferring the latest scientific findings into everyday healthcare. The editor
should enable the domain experts to model the clinical pathway on their own and
therefore closes the gap between development and implementation (domain- vs.
IT-specialists). The result of the translation process is the ready-to-use clinical
pathway for a specific target system. In addition, the HL7 representation ensures
a non-proprietary solution; for IT systems, which can import clinical pathways
using a HL7 interface, the last translation step is not even required. In con-
trast to other approaches in that research area, the whole development process
(definition, implementation, life-cycle management) is supported by information
technology. Each presented approach in Sect. 2 covers only one aspect of the
entire derivation process; a formal representation (see CIGs), the development
of concrete clinical pathways for one specific institution (manual process), or
the systematic translation (model-based approach). With the aid of information
technology it is expected that the development time of clinical pathways can be
reduced and the definition of guideline-compliant pathways can be ensured.
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