1、Designation:E221006 Designation: E2210 12An American National StandardStandard Specification forGuideline Elements Model version 23 (GEM III)DocumentModel for Clinical Practice Guidelines1This standard is issued under the fixed designation E2210; the number immediately following the designation indi
2、cates the year oforiginal adoption or, in the case 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. Scope *1.1 This specification updates a standard re
3、presentation for storing and organizing the heterogeneous information contained inclinical practice guidelines. This specification is intended to facilitate translation of natural-language guideline documents into aformat that can be processed by computers. It can be used to represent document conte
4、nt 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 elementsmodel (GEM) created at the Yale Center for Medical Informatics and designed to serve as a comprehensive XML-based guidelinedo
5、cument representation.1.2 This specification refers to and makes use of recommendations from the World Wide Web consortium, the W3C.21.3 Standard Guideline SchemaThis specification defines a standard Schema for clinical practice guidelines. The Schema isincluded in Annex A1.1.4 This standard does no
6、t purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatoryrequirements prior to use.2. Referenced Documents2.1 W3C World Wide
7、 Web Consortium:XML 1.0 Recommendation3XML Schema 1.043. Terminology3.1 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
8、 markup language (XML)standard from the World Wide Web Consortium (W3C) that provides for tagging ofinformation content within documents, offering a means of representation of content in a format that is both human and machinereadable. Through the use of customizable style sheets and schemas, inform
9、ation can be represented in a uniform way, allowingfor interchange of both content (data) and format (metadata).3.1.3 health level 7 (HL7)a standards organization traditionally focused on standards for healthcare information interchange.HL7 messages are the dominant standard for peer-to-peer exchang
10、e of clinical text-based information. More recently, HL7 hasdeveloped 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 document markup standard for the structure and semantics of exc
11、hangedclinical documents. A clinical document is a documentation of observations and other services with the following characteristics:persistence, stewardship, potential for authentication, wholeness, and human readability. A CDA document is a defined andcomplete information object that can exist o
12、utside 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 SGMLDTD. It provides tags regarding the way a document should be displayed in the text of an HTML document
13、, which act ascommands that a browser interprets when downloading an HTML file.3.1.6 namespacesprovide a simple method for qualifying element and attribute names used in XML documents. This is1This specification is under the jurisdiction of ASTM Committee E31 on Healthcare Informatics and is the dir
14、ect responsibility of Subcommittee E31.35 on HealthcareData Analysis.Current edition approved Dec.March 1, 2006.2012. Published January 2007.March 2012. Originally approved in 2002. Last previous edition approved in 20022006 asE2210 026. DOI: 10.1520/E2210-06.10.1520/E2210-12.2http:/www.w3.org3http:
15、/www.w3.org/XML/4http:/www.w3.org/XML/Schema1This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately,
16、 ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.acc
17、omplished by associating a particular tag set by associating a prefix with a URI reference. XML namespaces provides amechanism for authoring compound documents (documents consisting of elements and attributes from multiple DTDs or schemas)in such a way that will provide global identification without
18、 collisions of names that are the same but are used differently.3.1.7 parsera specialized software program that recognizes markup in a document and differentiates the content from themarkup. A parser that reads a DTD and checks and reports on markup errors is a validating XML parser. A parser can be
19、 built intoan XML editor to prevent incorrect tagging and to check whether a document contains all the required elements.3.1.8 XML Schemaprovides a means for defining the detailed structure, content and semantics of XML documents. XMLSchema was approved as a W3C Recommendation approved on 2 May 2001
20、 and with a second edition incorporating many erratawas published on 28 October 2004 that provides a means for defining the detailed structure, content and semantics of XMLdocuments. XML Schema defines the elements that can appear within the document and the attributes that can be associated withan
21、element. It also defines the structure of the document: which elements are child elements of others, the sequence in which thechild elements can appear, and the number of child elements. It defines whether an element is empty or can include text. Theschema can also define default values for attribut
22、es.3.1.9 stylesheetthe XSL transformations (XSLT) describes a vocabulary recognized by an XSLT processor to transforminformation from an organization in the source file into a different organization suitable for continued downstream processing. Theextensible stylesheet language (XSL) describes a voc
23、abulary recognized by a rendering agent to reify abstract expressions offormat into a particular medium of presentation.3.1.10 valid XML documenta document that is well-formed, with internal or DOCTYPE reference to element definition oftags within the document.3.1.11 well-formed XML documentan XML d
24、ocument that conforms to the syntax as specified by the W3C XML 1.0recommendation.3.1.12 World Wide Web Consortium (W3C)develops interoperable technologies (specifications, guidelines, software, andtools) to lead the Web to its full potential as a forum for information, commerce, communication, and
25、collective understanding.3.1.13 XHTMLHTML documents that are well formed and can be processed by an XML parser.3.1.14 XLL/XLINK/XPOINTERXLL, the extensible linking language, is divided into two parts, XLinks and XPointers.XLink, the XML linking language, defines how one document links to another doc
26、ument. 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 particularresource. The URLmay include an XPointer part that more specifically identifies the desired part or section of the targeted resour
27、ceor 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 morespecifically identifies the desired part or element o
28、f the targeted resource or document. XPointers use the same XPath syntax asXSL 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 guidelinessystematically developed stateme
29、nts to assist practitioner and patient decisions aboutappropriate healthcare for specific clinical circumstances.53.2.2 guideline elements model (GEM)an XML-based guideline document model that promotes translation of naturallanguage guideline documents into a format that can be processed by computer
30、s. Developed at the Yale Center for MedicalInformatics, GEM serves as the basis for this specification.63.2.3 guidelines interchange format (GLIF)a proposed representation for guideline logic created by the INTERMEDCollaboratory.73.2.4 national guidelines clearinghouse (NGC)a website sponsored by th
31、e U.S. Agency for Healthcare Quality and Researchthat disseminates information about qualifying guidelines. It includes a structured vocabulary for describing several aspects ofguidelines.83.3 GEM Definitions:3.3.1 See Table A1.1 in Annex A1.4. Significance and Use4.1 GEM RepresentationThe guideline
32、 elements model (GEM) was created to unify representations created by health servicesresearchers and by informatics specialists. Specification E2210 Schema is based on the GEM knowledge representation. It isintended to be:4.1.1 Comprehensive, that is, capable of expressing all the knowledge containe
33、d in a guideline. Existing health services modelsof guidelines are inadequate for expressing the complexity of knowledge components in sufficient detail to facilitate electronictranslations. On the other hand, existing informatics models are insufficient to model constructs that express and support
34、guidelinevalidity. Lack of confidence in the validity of guideline recommendations may ultimately limit end user adherence.5Guidelines for Clinical Practice: From Development to Use, Institute of Medicine, National Academy Press, Washington, DC, 1992.6http:/ycmi.med.yale.edu7http:/www.glif.org.8http
35、:/www.guideline.govE2210 1224.1.2 Expressively adequate to express the complexities and nuances of clinical medicine while remaining informationallyequivalent to the original guideline. Most tagged elements in the Specification E2210 Schema store the actual language of theguideline, thereby remainin
36、g true to the original. Moreover, this Schema does not require recommendation knowledge to bestructured in a temporal sequence, an often artificial transformation necessary for algorithmic representations.4.1.3 Flexible, that is, a useful model must be able to deal with the variety and complexity of
37、 guidelines. The representationshould 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 thehierarchy.
38、 In addition, the open XML document model can be modified easily if necessary to accommodate missing semanticconstructs.4.1.4 Comprehensible, that is, it should match the stakeholders normal problem-solving language and allow domain experts todescribe their knowledge with little effort. The Specific
39、ation E2210 Schema markup does not require knowledge 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 unparalleledcross-p
40、latform compatibility.4.1.6 Reusable across all phases of the guideline life cycle.4.2 ConformanceA document is tested for conformance to this specification by a validating XML parser according to theW3C XML 1.0 recommendation.9A conformant document must validate without either well-formedness or va
41、lidity 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 documentmust be valid according to the Sche
42、ma specified in this specification in order to conform to this specification.4.3 UseThe Guideline Elements Model has been the subject of considerable interest and application and has become theleading exemplar of document-centered guideline knowledge representation. It has been applied by national s
43、pecialty societies inthe U.S. for guideline development. Shahar in Israel has employed GEM within the DeGeLarchitecture to create a digital guidelinelibrary.10In Paris, Georg and colleagues found the GEM representation to be superior to their then current guideline system (ASTI)for encoding therapeu
44、tic guidelines.GEM has been incorporated within the GUIDE architecture in Pavia, Italy; it has been usedto teach informatics students about guidelines by Rector in the UK; it was incorporated within the CPGA architecture by Purvesin the UK; and it is being used in New Zealand for referral guideline
45、dissemination. In Canada, Jones has used GEM to generatetailored 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 guide
46、line recommendations into decision variables (and values), actions, anddirectives facilitates their encoding in controlled vocabularies such as SNOMED and LOINC and promotes the creation of rulesbased on the recommendations.5. Procedure5.1 GEM ArchitectureAs shown in Fig. 1, the root element contain
47、s two components: and. The next tier of the hierarchy defines a series of high-level elements that include, . , , , , , , , and elements. Each of these elements comprises one or moreadditional levels of guideline constructs.5.1.1The named global complex data type defines the “source,” “id,” and “lan
48、g” attributes. The “source”attribute distinguishes whether an elements content is explicitly stated within the guideline document or was inferred by the personwho performed the markup and takes values of “explicit,” “inferred,” or “not_defined.” The “id” attribute defines a uniqueidentifier for each
49、 element. The “lang” attribute indicates the language of the text content. , the root element containsthree components: , , and The next tier of the hierarchy defines a series of high-level elements that include , . , , , , , , , andelements. Each of these elements comprises one or more additional levels of guideline constructs.5.1.1 The named global complex data type defines the “source,” “version,” “id,” and “lang” attributes. The“source” attribute distinguishes whether an elements content is explicitly stated within the guideline document or was in
