4.1.3 Flexible, that is, a useful model must be able to deal
with the variety and complexity of guidelines. The representa-
tion should permit modeling at high and low levels of
granularity so that guidelines can be interpreted at different
levels of abstraction. The Specification E2210 Schema allows
markup using high-level tags or deeper analysis using elements
from lower levels in the hierarchy. In addition, the open XML
document model can be modified easily if necessary to
accommodate missing semantic constructs.
4.1.4 Comprehensible, that is, it should match the stake-
holders’ normal problem-solving language and allow domain
experts to describe their knowledge with little effort. The
Specification E2210 Schema markup does not require knowl-
edge of programming. The markup process parallels physical
highlighting of a document and should be learned easily by
nonprogrammers.
4.1.5 Shareable across institutions. The use of XML for
knowledge representation and markup provides unparalleled
cross-platform compatibility.
4.1.6 Reusable across all phases of the guideline life cycle.
4.2 Conformance—A document is tested for conformance to
this specification by a validating XML parser according to the
W3C XML 1.0 recommendation.
9
A conformant document
must validate without either well-formedness or validity errors,
according to XML 1.0. A conformant document must also
conform to constraints expressed within the prose of this
specification; however, this specification does not express a
formal means of testing conformance to such additional
constraints. A document must be valid according to the Schema
specified in this specification in order to conform to this
specification.
4.3 Use—The Guideline Elements Model has been the
subject of considerable interest and application and has become
the leading exemplar of document-centered guideline knowl-
edge representation. It has been applied by national specialty
societies in the U.S. for guideline development. Shahar in
Israel has employed GEM within the DeGeL architecture to
create a digital guideline library.
10
In Paris, Georg and col-
leagues found the GEM representation to be superior to their
then current guideline system (ASTI) for encoding therapeutic
guidelines.GEM has been incorporated within the GUIDE
architecture in Pavia, Italy; it has been used to teach informat-
ics students about guidelines by Rector in the UK; it was
incorporated within the CPGA architecture by Purves in the
UK; and it is being used in New Zealand for referral guideline
dissemination. In Canada, Jones has used GEM to generate
tailored patient education materials and Kershaw has applied
the system to create a web-enabled best-evidence retrieval
system. GEM is featured and linked on the Open Clinical
website in the UK.
4.3.1 Workers at Yale have found that parsing guideline
recommendations into decision variables (and values), actions,
and directives facilitates their encoding in controlled vocabu-
laries such as SNOMED and LOINC and promotes the creation
of rules based on the recommendations.
5. Procedure
5.1 GEM Architecture—As shown in Fig. 1, the root
<schema> element contains three components:
<GuidelineDocument>, <GemBasicType>, and <GemCode-
Type>.. The next tier of the <GuidelineDocument> hierarchy
defines a series of high-level elements that include <Identity>,
<Developer>. <Purpose>, <IntendedAudience>,
<MethodOfDevelopment>, <TargetPopulation>,
<KnowledgeComponents>, <Testing>, <RevisionPlan>, and
<ImplementationPlan> elements. Each of these elements
comprises one or more additional levels of guideline con-
structs.
5.1.1 The named global complex data type <GemBasic-
Type> defines the “source,” “version,” “id,” and “lang” attri-
butes. The “source” attribute distinguishes whether an el-
ement’s content is explicitly stated within the guideline
document or was inferred by the person who performed the
markup and takes values of “explicit,” “inferred,” or “not_
defined.” The “version” attribute defines the specific version of
the element.The “id” attribute defines a unique identifier for
each element. The “lang” attribute indicates the language of the
text content.
5.1.2 The named global complex data type <GemCode-
Type> defines the”source,” “version,” “codeset,” “id,” and
“lang” attributes. The “source” attribute distinguishes whether
an element’s content is explicitly stated within the guideline
document or was inferred by the person who performed the
markup and takes values of “explicit,” “inferred,” or “not_
defined.” The “version” attribute defines the specific version of
the element. The “codeset” attribute identifies the name of the
dataset o f concept identifiers for each element. The “id”
attribute defines a unique identifier for each element. The
“lang” attribute indicates the language of the text content.
5.2 Components:
5.2.1 Elements—Elements can appear as often as required.
Most elements store information that is literally presented in
the guideline text itself, for example, release date, name of
sponsoring organization, and recommendation text. Element
definitions are provided in Table A1.1.
5.2.2 Data Types—Elements are of type GemBasicType or
GemCodeType or contain the GemBasicType or GemCode-
Type attributes.
5.2.3 Annotations—Annotations contain definitions of ele-
ments.
5.2.4 Codes—The elements DecisionVariableCode,
ActionCode, DirectiveCode, RecommendationStrengthCode,
InclusionCriterionCode, ExclusionCriterionCode, and Scope-
Code contain letters or digits that are used for identification or
selection purposes. The system from which the code originates
isspecified in the “codeset” attribute.
9
http://www.w3.org/TR/2000/REC-xml-20001006
10
Shahar, Y., Shalom, E., Mayaffit, A., Young, O., Galperin, M., Martins, S., et
al, “A Distributed, Collabaorative, Structuring Model for a Clinical-Guideline
Digital-Library,” Musen, M. A., editor, AMIA 2003 Symposium, Washington, DC,
2003, pp. 589-593.
E2210 − 12
3