1、Designation: E 2210 06An American National StandardStandard Specification forGuideline Elements Model version 2 (GEM II)DocumentModel for Clinical Practice Guidelines1This standard is issued under the fixed designation E 2210; the number immediately following the designation indicates the year ofori
2、ginal adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification updates a standard representation forstor
3、ing and organizing the heterogeneous information con-tained in clinical practice guidelines. This specification isintended to facilitate translation of natural-language guidelinedocuments into a format that can be processed by computers. Itcan be used to represent document content throughout theenti
4、re guideline life cycle. Information at both high and lowlevels of abstraction can be accommodated. This specificationis based on the guideline elements model (GEM) created at theYale Center for Medical Informatics and designed to serve asa comprehensive XML-based guideline document representa-tion.
5、1.2 This specification refers to and makes use of recommen-dations from the World Wide Web consortium, the W3C.21.3 Standard Guideline SchemaThis specification definesa standard Schema for clinical practice guidelines. The Schemais included in Annex A1.1.4 This standard does not purport to address a
6、ll of thesafety concerns, if any, associated with its use. It is theresponsibility 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 Documents2.1 W3C World Wide Web Consortium:XML
7、1.0 Recommendation3XML Schema 1.043. Terminology3.1 Definitions:3.1.1 document type definition (DTD)the formal defini-tion of the elements, structures, and rules for enablingplatform-independent data access via XML, or for marking upa given type of SGML document.3.1.2 extensible markup language (XML
8、)standard fromthe World Wide Web Consortium (W3C) that provides fortagging of information content within documents, offering ameans of representation of content in a format that is bothhuman and machine readable. Through the use of customizablestyle sheets and schemas, information can be represented
9、 in auniform 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-bas
10、ed information. Morerecently, HL7 has developed a comprehensive object model ofthe healthcare enterprise and the first level of an XML clinicaldocument architecture.3.1.4 HL7 clinical document architecture (CDA)a docu-ment markup standard for the structure and semantics ofexchanged clinical document
11、s. A clinical document is a docu-mentation of observations and other services with the follow-ing characteristics: persistence, stewardship, potential for au-thentication, wholeness, and human readability. A CDAdocument is a defined and complete information object that canexist outside of a message
12、and can include text, sounds, andother multimedia content.3.1.5 hypertext markup language (HTML)the languageused in creating a web page. Its origin is an implementation ofSGML DTD. It provides tags regarding the way a documentshould be displayed in the text of an HTML document, whichact as commands
13、that a browser interprets when downloadingan HTML file.3.1.6 namespacesprovide a simple method for qualifyingelement and attribute names used in XML documents. This isaccomplished by associating a particular tag set by associatinga prefix with a URI reference. XML namespaces provides amechanism for
14、authoring compound documents (documentsconsisting of elements and attributes from multiple DTDs orschemas) in such a way that will provide global identificationwithout collisions of names that are the same but are useddifferently.3.1.7 parsera specialized software program that recog-nizes markup in
15、a document and differentiates the content fromthe markup. A parser that reads a DTD and checks and reportson markup errors is a validating XML parser. A parser can be1This specification is under the jurisdiction of ASTM Committee E31 onHealthcare Informatics and is the direct responsibility of Subco
16、mmittee E31.35 onHealthcare Data Analysis.Current edition approved Dec. 1, 2006. Published January 2007. Originallyapproved in 2002. Last previous edition approved in 2002 as E 2210 02.2http:/www.w3.org3http:/www.w3.org/XML/4http:/www.w3.org/XML/Schema1*A Summary of Changes section appears at the en
17、d of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.built into an XML editor to prevent incorrect tagging and tocheck whether a document contains all the required elements.3.1.8 XML Schemaprovides a means for defining t
18、hedetailed structure, content and semantics of XML documents.XML Schema was approved as a W3C Recommendationapproved on 2 May 2001 and with a second edition incorpo-rating many errata was published on 28 October 2004 thatprovides a means for defining the detailed structure, contentand semantics of X
19、ML documents. XML Schema defines theelements that can appear within the document and the attributesthat can be associated with an element. It also defines thestructure of the document: which elements are child elementsof others, the sequence in which the child elements can appear,and the number of c
20、hild elements. It defines whether anelement is empty or can include text. The schema can alsodefine default values for attributes.3.1.9 stylesheetthe XSL transformations (XSLT) de-scribes a vocabulary recognized by an XSLT processor totransform information from an organization in the source fileinto
21、 a different organization suitable for continued downstreamprocessing. The extensible stylesheet language (XSL) de-scribes a vocabulary recognized by a rendering agent to reifyabstract expressions of format into a particular medium ofpresentation.3.1.10 valid XML documenta document that is well-form
22、ed, with internal or DOCTYPE reference to elementdefinition of tags within the document.3.1.11 well-formed XML documentan XML documentthat conforms to the syntax as specified by the W3C XML 1.0recommendation.3.1.12 World Wide Web Consortium (W3C)develops in-teroperable technologies (specifications,
23、guidelines, software,and tools) to lead the Web to its full potential as a forum forinformation, commerce, communication, and collective under-standing.3.1.13 XHTMLHTML documents that are well formedand can be processed by an XML parser.3.1.14 XLL/XLINK/XPOINTERXLL, the extensible link-ing language,
24、 is divided into two parts, XLinks and XPointers.XLink, the XML linking language, defines how one documentlinks to another document. XPointer, the XML pointer lan-guage, defines how individual parts of a document are ad-dressed. XLinks point to a URI (in practice, a URL) thatspecifies a particular r
25、esource. The URL may include anXPointer part that more specifically identifies the desired partor section of the targeted resource or document. XPointer, theXML pointer language, defines an addressing scheme forindividual parts of an XML document. XLinks point to a URI(in practice, a URL) that speci
26、fies a particular resource. TheURI may include an XPointer part that more specificallyidentifies the desired part or element of the targeted resource ordocument. XPointers use the same XPath syntax as XSLtransformations to identify the parts of the document they pointto, along with a few additional
27、pieces.3.2 Definitions of Terms Specific to This Standard:3.2.1 clinical practice guidelinessystematically devel-oped statements to assist practitioner and patient decisionsabout appropriate healthcare for specific clinical circum-stances.53.2.2 guideline elements model (GEM)an XML-basedguideline do
28、cument model that promotes translation of naturallanguage guideline documents into a format that can beprocessed by computers. Developed at the Yale Center forMedical Informatics, GEM serves as the basis for this speci-fication.63.2.3 guidelines interchange format (GLIF)a proposedrepresentation for
29、guideline logic created by the INTERMEDCollaboratory.73.2.4 national guidelines clearinghouse (NGC)a websitesponsored by the U.S. Agency for Healthcare Quality andResearch that disseminates information about qualifying guide-lines. It includes a structured vocabulary for describing severalaspects of
30、 guidelines.83.3 GEM Definitions:3.3.1 See Table A1.1 in Annex A1.4. Significance and Use4.1 GEM RepresentationThe guideline elements model(GEM) was created to unify representations created by healthservices researchers and by informatics specialists. Specifica-tion E 2210 Schema is based on the GEM
31、 knowledge repre-sentation. It is intended to be:4.1.1 Comprehensive, that is, capable of expressing all theknowledge contained in a guideline. Existing health servicesmodels of guidelines are inadequate for expressing the com-plexity of knowledge components in sufficient detail to facili-tate elect
32、ronic translations. On the other hand, existing infor-matics models are insufficient to model constructs that expressand support guideline validity. Lack of confidence in thevalidity of guideline recommendations may ultimately limitend user adherence.4.1.2 Expressively adequate to express the comple
33、xities andnuances of clinical medicine while remaining informationallyequivalent to the original guideline. Most tagged elements inthe Specification E 2210 Schema store the actual language ofthe guideline, thereby remaining true to the original. Moreover,this Schema does not require recommendation k
34、nowledge to bestructured in a temporal sequence, an often artificial transfor-mation necessary for algorithmic representations.4.1.3 Flexible, that is, a useful model must be able to dealwith the variety and complexity of guidelines. The representa-tion should permit modeling at high and low levels
35、ofgranularity so that guidelines can be interpreted at differentlevels of abstraction. The Specification E 2210 Schema allowsmarkup using high-level tags or deeper analysis using elementsfrom lower levels in the hierarchy. In addition, the open XMLdocument model can be modified easily if necessary t
36、oaccommodate missing semantic constructs.5Guidelines for Clinical Practice: From Development to Use, Institute ofMedicine, National Academy Press, Washington, DC, 1992.6http:/ycmi.med.yale.edu7http:/www.glif.org.8http:/www.guideline.govE22100624.1.4 Comprehensible, that is, it should match the stake
37、-holders normal problem-solving language and allow domainexperts to describe their knowledge with little effort. TheSpecification E 2210 Schema markup does not require knowl-edge of programming. The markup process parallels physicalhighlighting of a document and should be learned easily bynonprogram
38、mers.4.1.5 Shareable across institutions. The use of XML forknowledge representation and markup provides unparalleledcross-platform compatibility.4.1.6 Reusable across all phases of the guideline life cycle.4.2 ConformanceA document is tested for conformanceto this specification by a validating XML
39、parser according tothe W3C XML 1.0 recommendation.9A conformant documentmust validate without either well-formedness or validity errors,according to XML 1.0. A conformant document must alsoconform to constraints expressed within the prose of thisspecification; however, this specification does not ex
40、press aformal means of testing conformance to such additionalconstraints.Adocument must be valid according to the Schemaspecified in this specification in order to conform to thisspecification.4.3 UseThe Guideline Elements Model has been thesubject of considerable interest and application and has be
41、comethe leading exemplar of document-centered guideline knowl-edge representation. It has been applied by national specialtysocieties in the U.S. for guideline development. Shahar inIsrael has employed GEM within the DeGeL architecture tocreate a digital guideline library.10In Paris, Georg and col-l
42、eagues found the GEM representation to be superior to theirthen current guideline system (ASTI) for encoding therapeuticguidelines.GEM has been incorporated within the GUIDEarchitecture in Pavia, Italy; it has been used to teach informat-ics students about guidelines by Rector in the UK; it wasincor
43、porated within the CPGA architecture by Purves in theUK; and it is being used in New Zealand for referral guidelinedissemination. In Canada, Jones has used GEM to generatetailored patient education materials and Kershaw has appliedthe system to create a web-enabled best-evidence retrievalsystem. GEM
44、 is featured and linked on the Open Clinicalwebsite in the UK.4.3.1 Workers at Yale have found that parsing guidelinerecommendations into decision variables (and values), actions,and directives facilitates their encoding in controlled vocabu-laries such as SNOMED and LOINC and promotes the creationo
45、f rules based on the recommendations.5. Procedure5.1 GEM ArchitectureAs shown in Fig. 1, the rootelement contains two components: and . The next tier of thehierarchy defines a series of high-levelelements that include , . ,9http:/www.w3.org/TR/2000/REC-xml-2000100610Shahar, Y., Shalom, E., Mayaffit,
46、 A., Young, O., Galperin, M., Martins, S., etal, “A Distributed, Collabaorative, Structuring Model for a Clinical-GuidelineDigital-Library,” Musen, M. A., editor, AMIA 2003 Symposium, Washington, DC,2003, pp. 589-593.FIG. 1 Top Level of the GEM II SchemaE2210063, , , , , , and elements. Each of thes
47、eelements comprises one or more additional levels of guidelineconstructs.5.1.1 The named global complex data type defines the “source,” “id,” and “lang” attributes. The“source” attribute distinguishes whether an elements contentis explicitly stated within the guideline document or wasinferred by the
48、 person who performed the markup and takesvalues of “explicit,” “inferred,” or “not_defined.” 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 ElementsElements can appear as often as required.Most elem
49、ents store information that is literally presented inthe guideline text itself, for example, release date, name ofsponsoring organization, and recommendation text. Elementdefinitions are provided in Table A1.1.5.2.2 Data TypesElements are of type GemBasicType orcontain the GemBasicType attributes.5.2.3 AnnotationsAnnotations contain definitions of ele-ments.5.3 NamespaceThe target and default namespace decla-rations are “http:/gem.yale.edu.” The prefix for the XMLNamespace “http:/www.w3.org/2001/XMLSchema” is “xs.”5.4 IdentityInformation that ide
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