1、Designation: E2210 12Standard Specification forGuideline Elements Model version 3 (GEM III)DocumentModel for Clinical Practice Guidelines1This standard is issued under the fixed designation E2210; the number immediately following the designation indicates the year oforiginal adoption or, in the case
2、 of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification updates a standard representation forstoring and organizing the heterogen
3、eous 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 theentire guideline life cycle. Informa
4、tion 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.1.2 This specification refers to
5、 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 all of thesafety concerns, if any
6、, 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.1.5 This international standard was developed in accor-dance with internationally recognized
7、principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 W3C World Wide Web Consortium:XML 1.0 Recom
8、mendation3XML Schema 1.043. Terminology3.1 Definitions:3.1.1 document type definition (DTD)the formal definitionof the elements, structures, and rules for enabling platform-independent data access via XML, or for marking up a giventype of SGML document.3.1.2 extensible markup language (XML)standard
9、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 in aunifo
10、rm 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 informa
11、tion. 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 documents. A clini
12、cal document is a docu-mentation of observations and other services with the follow-ing characteristics: persistence, stewardship, potential forauthentication, wholeness, and human readability. A CDAdocument is a defined and complete information object that canexist outside of a message and can incl
13、ude text, sounds, andother multimedia content.1This specification is under the jurisdiction of ASTM Committee E31 onHealthcare Informatics and is the direct responsibility of Subcommittee E31.35 onHealthcare Data Analysis.Current edition approved March 1, 2012. Published March 2012. Originallyapprov
14、ed in 2002. Last previous edition approved in 2006 as E2210 06. DOI:10.1520/E2210-12.2http:/www.w3.org3http:/www.w3.org/XML/4http:/www.w3.org/XML/SchemaCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was dev
15、eloped in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.13.1.5 hypertext m
16、arkup 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 that a browser interprets when downloadingan HTML file.3.1.6 namespacesprov
17、ide 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 authoring compound documents (documentsconsisting of elements and attribute
18、s 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 a document and differentiates the content fromthe markup. A parser that rea
19、ds a DTD and checks and reportson markup errors is a validating XML parser. A parser can bebuilt 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 thedetailed structure, content and semantic
20、s 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 XML documents. XML Schema defines theelemen
21、ts 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 child elements. It defines whether anelemen
22、t 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 a different organization suitable for con
23、tinued 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-formed, with internal or DOCTYPE reference to
24、elementdefinition of tags within the document.3.1.11 well-formed XML documentan XMLdocument thatconforms to the syntax as specified by the W3C XML 1.0recommendation.3.1.12 World Wide Web Consortium (W3C)develops in-teroperable technologies (specifications, guidelines, software,and tools) to lead the
25、 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, is divided into two parts, XLinks and XPoi
26、nters.XLink, the XML linking language, defines how one documentlinks to another document. XPointer, the XML pointerlanguage, defines how individual parts of a document areaddressed. XLinks point to a URI (in practice, a URL) thatspecifies a particular resource. The URL may include anXPointer part th
27、at 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 specifies a particular resource. TheURI may include
28、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 pieces.3.2 Definitions of Terms Specific to Thi
29、s 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 document model that promotes translation of natur
30、allanguage 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 guideline logic created by the INTERMEDCollabor
31、atory.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 guidelines.83.3 GEM Definitions:3.3.1 See Tabl
32、e 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 E2210 Schema is based on the GEM knowledge represen-tation. It is intended to be
33、: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 electronic translations. On the other hand, existing
34、infor-matics models are insufficient to model constructs that express5Guidelines 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.govE2210 122and support guideline valid
35、ity. Lack of confidence in thevalidity of guideline recommendations may ultimately limitend user adherence.4.1.2 Expressively adequate to express the complexities andnuances of clinical medicine while remaining informationallyequivalent to the original guideline. Most tagged elements inthe Specifica
36、tion E2210 Schema store the actual language ofthe guideline, thereby remaining true to the original. Moreover,this Schema does not require recommendation knowledge to bestructured in a temporal sequence, an often artificial transfor-mation necessary for algorithmic representations.4.1.3 Flexible, th
37、at 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 ofgranularity so that guidelines can be interpreted at differentlevels of abstraction. The Specification E2210 Schema allowsmarkup using high-lev
38、el tags or deeper analysis using elementsfrom lower levels in the hierarchy. In addition, the open XMLdocument model can be modified easily if necessary toaccommodate missing semantic constructs.4.1.4 Comprehensible, that is, it should match the stake-holders normal problem-solving language and allo
39、w domainexperts to describe their knowledge with little effort. TheSpecification E2210 Schema markup does not require knowl-edge of programming. The markup process parallels physicalhighlighting of a document and should be learned easily bynonprogrammers.4.1.5 Shareable across institutions. The use
40、of XML forknowledge representation and markup provides unparalleledcross-platform compatibility.4.1.6 Reusable across all phases of the guideline life cycle.4.2 ConformanceAdocument is tested for conformance tothis specification by a validating XML parser according to theW3C XML 1.0 recommendation.9
41、A 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 express aformal means of testing conformance to such
42、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 becomethe leading exemplar of document-centered guide
43、line 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-leagues found the GEM representation to be superior
44、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 wasincorporated within the CPGA architecture by Purves in t
45、heUK; 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 is featured and linked on the Open Clinicalwebsite
46、 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 creationof rules based on the recommendations.5. Procedure5.
47、1 GEM ArchitectureAs shown in Fig. 1, the rootelement contains three components:, , and The next tier of the hierarchydefines a series of high-level elements that include ,. , , , , , andelements. Each of these elementscomprises one or more additional levels of guideline con-structs.5.1.1 The named
48、global complex data type defines the “source,” “version,” “id,” and “lang” attri-butes. The “source” attribute distinguishes whether an el-ements content is explicitly stated within the guidelinedocument or was inferred by the person who performed themarkup and takes values of “explicit,” “inferred,
49、” or “not_defined.” The “version” attribute defines the specific version ofthe element.The “id” attribute defines a unique identifier foreach element. The “lang” attribute indicates the language of thetext content.5.1.2 The named global complex data type defines the”source,” “version,” “codeset,” “id,” and“lang” attributes. The “source” attribute distinguishes whetheran elements content is explicitly stated within the guidelinedocument or was inferred by the person who performed themarkup and takes values of “explicit,” “inferred,” or “not_defined.”
