ASTM E2210 - 12

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Designation: E2210 −12 An American National Standard
Standard Specification for
Guideline Elements Model version 3 (GEM III)—Document
Model for Clinical Practice Guidelines
1
This standard is issued under the fixed designation E2210; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This specification updates a standard representation for
storing and organizing the heterogeneous information con-
tained in clinical practice guidelines. This specification is
intended to facilitate translation of natural-language guideline
documents into a format that can be processed by computers. It
can be used to represent document content throughout the
entire guideline life cycle. Information at both high and low
levels of abstraction can be accommodated. This specification
is based on the guideline elements model (GEM) created at the
Yale Center for Medical Informatics and designed to serve as
a comprehensive XML-based guideline document representa-
tion.
1.2 This specification refers to and makes use of recommen-
dations from the World Wide Web consortium, the W3C.
2
1.3 Standard Guideline Schema—This specification defines
a standard Schema for clinical practice guidelines. The Schema
is included in Annex A1.
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
bility of regulatory requirements prior to use.
2. Referenced Documents
2.1 W3C World Wide Web Consortium:
XML 1.0 Recommendation
3
XML Schema 1.0
4
3. Terminology
3.1 Definitions:
3.1.1 document type definition (DTD)—the formal definition
of the elements, structures, and rules for enabling platform-
independent data access via XML, or for marking up a given
type of SGML document.
3.1.2 extensible markup language (XML)—standard from
the World Wide Web Consortium (W3C) that provides for
tagging of information content within documents, offering a
means of representation of content in a format that is both
human and machine readable. Through the use of customizable
style sheets and schemas, information can be represented in a
uniform way, allowing for interchange of both content (data)
and format (metadata).
3.1.3 health level 7 (HL7)—a standards organization tradi-
tionally focused on standards for healthcare information inter-
change. HL7 messages are the dominant standard for peer-to-
peer exchange of clinical text-based information. More
recently, HL7 has developed a comprehensive object model of
the healthcare enterprise and the first level of an XML clinical
document architecture.
3.1.4 HL7 clinical document architecture (CDA)—a docu-
ment markup standard for the structure and semantics of
exchanged clinical documents. A clinical document is a docu-
mentation of observations and other services with the follow-
ing characteristics: persistence, stewardship, potential for
authentication, wholeness, and human readability. A CDA
document is a defined and complete information object that can
exist outside of a message and can include text, sounds, and
other multimedia content.
3.1.5 hypertext markup language (HTML)—the language
used in creating a web page. Its origin is an implementation of
SGML DTD. It provides tags regarding the way a document
should be displayed in the text of an HTML document, which
act as commands that a browser interprets when downloading
an HTML file.
3.1.6 namespaces—provide a simple method for qualifying
element and attribute names used in XML documents. This is
accomplished by associating a particular tag set by associating
a prefix with a URI reference. XML namespaces provides a
mechanism for authoring compound documents (documents
consisting of elements and attributes from multiple DTDs or
1
This specification is under the jurisdiction of ASTM Committee E31 on
Healthcare Informatics and is the direct responsibility of Subcommittee E31.35 on
Healthcare Data Analysis.
Current edition approved March 1, 2012. Published March 2012. Originally
approved in 2002. Last previous edition approved in 2006 as E2210 – 06. DOI:
10.1520/E2210-12.
2
http://www.w3.org
3
http://www.w3.org/XML/
4
http://www.w3.org/XML/Schema
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
schemas) in such a way that will provide global identification
without collisions of names that are the same but are used
differently.
3.1.7 parser—a specialized software program that recog-
nizes markup in a document and differentiates the content from
the markup. A parser that reads a DTD and checks and reports
on markup errors is a validating XML parser. A parser can be
built into an XML editor to prevent incorrect tagging and to
check whether a document contains all the required elements.
3.1.8 XML Schema—provides a means for defining the
detailed structure, content and semantics of XML documents.
XML Schema was approved as a W3C Recommendation
approved on 2 May 2001 and with a second edition incorpo-
rating many errata was published on 28 October 2004 that
provides a means for defining the detailed structure, content
and semantics of XML documents. XML Schema defines the
elements that can appear within the document and the attributes
that can be associated with an element. It also defines the
structure of the document: which elements are child elements
of others, the sequence in which the child elements can appear,
and the number of child elements. It defines whether an
element is empty or can include text. The schema can also
define default values for attributes.
3.1.9 stylesheet—the XSL transformations (XSLT) de-
scribes a vocabulary recognized by an XSLT processor to
transform information from an organization in the source file
into a different organization suitable for continued downstream
processing. The extensible stylesheet language (XSL) de-
scribes a vocabulary recognized by a rendering agent to reify
abstract expressions of format into a particular medium of
presentation.
3.1.10 valid XML document—a document that is well-
formed, with internal or DOCTYPE reference to element
definition of tags within the document.
3.1.11 well-formed XML document—an XML document that
conforms to the syntax as specified by the W3C XML 1.0
recommendation.
3.1.12 World Wide Web Consortium (W3C)—develops in-
teroperable technologies (specifications, guidelines, software,
and tools) to lead the Web to its full potential as a forum for
information, commerce, communication, and collective under-
standing.
3.1.13 XHTML—HTML documents that are well formed
and can be processed by an XML parser.
3.1.14 XLL/XLINK/XPOINTER—XLL, the extensible link-
ing language, is divided into two parts, XLinks and XPointers.
XLink, the XML linking language, defines how one document
links to another document. XPointer, the XML pointer
language, defines how individual parts of a document are
addressed. XLinks point to a URI (in practice, a URL) that
specifies a particular resource. The URL may include an
XPointer part that more specifically identifies the desired part
or section of the targeted resource or document. XPointer, the
XML pointer language, defines an addressing scheme for
individual parts of an XML document. XLinks point to a URI
(in practice, a URL) that specifies a particular resource. The
URI may include an XPointer part that more specifically
identifies the desired part or element of the targeted resource or
document. XPointers use the same XPath syntax as XSL
transformations to identify the parts of the document they point
to, along with a few additional pieces.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 clinical practice guidelines—systematically devel-
oped statements to assist practitioner and patient decisions
about appropriate healthcare for specific clinical circum-
stances.
5
3.2.2 guideline elements model (GEM)—an XML-based
guideline document model that promotes translation of natural
language guideline documents into a format that can be
processed by computers. Developed at the Yale Center for
Medical Informatics, GEM serves as the basis for this speci-
fication.
6
3.2.3 guidelines interchange format (GLIF)—a proposed
representation for guideline logic created by the INTERMED
Collaboratory.
7
3.2.4 national guidelines clearinghouse (NGC)—a website
sponsored by the U.S. Agency for Healthcare Quality and
Research that disseminates information about qualifying guide-
lines. It includes a structured vocabulary for describing several
aspects of guidelines.
8
3.3 GEM Definitions:
3.3.1 See Table A1.1 in Annex A1.
4. Significance and Use
4.1 GEM Representation—The guideline elements model
(GEM) was created to unify representations created by health
services researchers and by informatics specialists. Specifica-
tion E2210 Schema is based on the GEM knowledge represen-
tation. It is intended to be:
4.1.1 Comprehensive, that is, capable of expressing all the
knowledge contained in a guideline. Existing health services
models of guidelines are inadequate for expressing the com-
plexity of knowledge components in sufficient detail to facili-
tate electronic translations. On the other hand, existing infor-
matics models are insufficient to model constructs that express
and support guideline validity. Lack of confidence in the
validity of guideline recommendations may ultimately limit
end user adherence.
4.1.2 Expressively adequate to express the complexities and
nuances of clinical medicine while remaining informationally
equivalent to the original guideline. Most tagged elements in
the Specification E2210 Schema store the actual language of
the guideline, thereby remaining true to the original. Moreover,
this Schema does not require recommendation knowledge to be
structured in a temporal sequence, an often artificial transfor-
mation necessary for algorithmic representations.
5
Guidelines for Clinical Practice: From Development to Use, Institute of
Medicine, National Academy Press, Washington, DC, 1992.
6
http://ycmi.med.yale.edu
7
http://www.glif.org.
8
http://www.guideline.gov
E2210 − 12
2
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
摘要:

ASTM E2210 - 12 是国际标准组织 ASTM 制定的一项关于屋面系统用板式隔热材料的标准规范,主要适用于建筑屋顶结构中使用的聚异氰脲酸酯(PIR)或聚氨酯(PUR)硬质泡沫塑料板的性能要求与测试方法。该标准规定了材料的密度、压缩强度、尺寸稳定性、热阻值、吸水率及抗老化等关键指标,旨在确保隔热材料在长期使用中的可靠性与节能效果。版本中的“12”代表该标准于2012年发布,适用于建筑节能设计与施工中材料选型和质量控制。遵循此标准有助于提升屋顶系统的耐久性,减少热损失,适应不同气候条件下的

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