1. Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 / WG II

2. Contents what is a clinical template ? batteries, data sets, reusable fragments of messages 3 pillars for semantic interoperability repositories, templates, value domains HL7 light: a complementary approach –decentralisation of a registration process –involvement of professionals and agencies –a common strategy for HL7 and CEN ?

3. what is a template ? too many legitimate perspectives and options

4. battery in HL71/5 battery: a set of one or more observations identified as by a single name and code number, and treated as a shorthand unit for ordering or retrieving results of the constituent observations. … Vital signs, electrolytes, routine admission tests, and obstetrical ultrasound are all examples.

5. battery in HL72/5 "Vital signs (conventionally) consist of diastolic and systolic blood pressure, pulse, and respiratory rate. Electrolytes usually consist of Na+, K+, Cl-, and HCO3-. Routine admission tests might contain CBC, Electrolytes, SMA12, and Urinalysis. (Note that the elements of a battery for our purposes may also be batteries). "

6. battery in HL73/5 "Obstetrical ultrasound is a battery made up of traditional component measurements and the impression, all of which would be returned as separate results when returned to the requestor. "

7. battery in HL74/5 "A test involving waveform recording (such as an EKG) can be represented as a battery made up of results of many categories, including digital waveform data, labels and annotations to the data, measurements, and the impression. "

8. battery in HL75/5 "The word battery is used in this specification synonymously with the words profile or panel. The individual observation elements within a battery may be characteristic of a physiologic system (e.g., liver function tests), or many different physiologic systems.

9. Crucial issues Version 2.x provides no rules for harmonization / registration of batteries Constituent elements of a battery must be predefined –Need for a registry of data elements –Need for computable value domains (numeric ranges, code sets)

10. Example on Lab Data results [from HL7 version 2, § 7.4.3] OBR|1|870930010^OE|CM3562^LAB| 80004^ELECTROLYTES|… OBX|1|ST|84295^NA||150|mmol/l|136-148|... OBX|2|ST|84132^K+||4.5|mmol/l|3.5-5|... OBX|3|ST|82435^CL||102|mmol/l|94-105|... OBX|4|ST|82374^CO2||27|mmol/l|24-31|…

11. Option 1: master tables the content of the "electrolytes template is a set of 4 OBXs with locally predefined names and units. For example, stored in Master Tables Only the template name is sent in the order Numeric values will be filled in at the instantiation How can we harmonize definitions across master tables of different organizations ?

12. negotiating the template the master table approach involves a negotiation between sender and receiver they exchange the definition of template,they exchange the definition of template, they refine itthey refine it - how to assure version identification ? - is it safe to send only the template name in an order, without the detail on content ?

13. NEW: panel names in LOINC [from LOINC, vers. June 2000, at www.regenstrief.org/loinc] hemogram panel (code=24358-4) panel elements =erythrocytes; leukocytes; hematocrit; hemoglobin; MCV; MCH; MCHC; RDW hemogram & platelets panel (code=24317-0) panel elements =hemogram panel; platelets; MPV

14. option 2: LOINC+ as register first 51 panels are availablefirst 51 panels are available fast and reactive maintenance processfast and reactive maintenance process LOINC could be a good source for names and codes of templates but description of content is text-based, i.e. –ranges are not computer-processable –value sets do not use LOINC codes is the description defining the template ? which change justifies a new template ?

15. Example on Medical Record in HL7 [from HL7 version 2, § 9.6] TXA|0001|HP^history & physical|TX^text| … OBX|1|CE|2000.40^CHIEF COMPLAINT||... OBX|2|ST|2000.01^SOURCE||PATIENT... OBX|3|TX|2000.02^PRESENT ILLNESS| |SUDDEN ONSET OF CHEST PAIN. 2 DAYS, PTA ASSOCIATED WITH NAUSEA, VOMITING & SOB. NO RELIEF WITH ANTACIDS …

16. option 3: set of detailed standards CHIEF COMPLAINT SOURCE PRESENT ILLNESS … how to obtain wide consensus on section of documents ? see standardization initiatives in ASTM 31.25 andASTM 31.25 and Clinical Doc. Architecture level 2 (PRA)Clinical Doc. Architecture level 2 (PRA)

17. Systematic rules for composition Template: systolic blood pressure OBX for systolic BP qualifiers: –patient's position –device –measurement site the circumstances of the measurement could be: additional OBXsadditional OBXs coded elements in a compositional data typecoded elements in a compositional data type detail within a molecular codedetail within a molecular code

18. option 4: combinatorial codes the observation code for systolic BP can be either a single molecular code or a combination of codes on –patient's position –device –measurement site We must control the overlap between terminological component of observation code explicit RIM attributes (rules for combinatorial codes are managed by coding system developers)

19. recurring subsegments [from ENV 12610, Medicinal product identification, Table 5.2.2 : Trade medicinal product identifiers] clinical template: clinical template: trade trade unique contents: group nametrade ID 4.2.1medicinal product designation x x x designation x x x 4.2.8dosage form x x 4.2.14route of administration x x 4.2.6strength x x 4.2.11medicinal product batch number x batch number x

20. option 5: RMIM - CMET define new (local) templates applying the same development methodology conceived for standard messages in HL7 need for thousands of data elementsneed for thousands of data elements as (local) extensions of the RIM need for a registry of templates ?need for a registry of templates ?

21. Schemas (e.g. BizTalk) [from the iEHR schema, by iSoft, at www.biztalk.org] </ElementType>

22. option 6: XML family 1. define XML labels 2. define their combination by measures external to HL7 constructs (e.g. XML schemas ?) in Biztalk (not limited to healthcare):in Biztalk (not limited to healthcare): –meaning of labels and value sets are not described ! –no comparison of XML tags from different vendors ! in ebXML (not limited to healthcare) :in ebXML (not limited to healthcare) : –registries ? a specific HL7 registry with XML.org ?a specific HL7 registry with XML.org ?

23. Conditional templates 1/3 [from the CDC form for Hepatitis A notification] BASIS FOR DIAGNOSIS CLINICAL DATA Symptomatic ? yes no unknown if yes, Onset date ____ Diarrhea yes no if yes, from ____ to ____ if yes, from ____ to ____ Jaundiced yes no Hospitalized yes no Died yes no LABORATORY TESTS...

24. Conditional templates 2/3 Diarrhea yes no if yes, from ___ to ___ Diarrhea is a finding, with boolean values. The above structure could be generalised as: Template: boolean finding with dates booleanFinding^LOINC^code | booleanValue if booleanValue = yes –starting date^LOINC^2345-7 | date –ending date^LOINC^3456-8 | date

25. Conditional templates 3/3 Template: boolean finding with dates booleanFinding^LOINC^code | booleanValue if booleanValue =... Refinement of template: conditional block: diarrhea with dates diarrhea^LOINC^1234-6 | booleanValuediarrhea^LOINC^1234-6 | booleanValue if booleanValue = yes –starting date^LOINC^2345-7 | date –ending date^LOINC^3456-8 | date

26. option 7: Arden syntax Arden syntax is the existing mechanismArden syntax is the existing mechanism for if-then rules it is harmonized with RIM and HDFit is harmonized with RIM and HDF it could be extended for this purpose (a special mechanism just for this kind of template …)

27. Clinical check list ? ( … DICOM ) [from Nomenclature of Digestive Endoscopy, OMED 1994] template name: description of duodenoscopy data elements value domain (for duodenoscopy) lumen {normal, spasm, stenosis, …} contents {blood, biliary stones, parasites, …} wall {rigid, decreased distensibility, …} mucosa {atrophic, granular, hyperemic, …} hemorrhage {mucosal bleeding, varices, …} flat lesions {aphta, infiltration, …} protrusions {papule, polyp, …} …...

28. Legal data sets ? [from the Belgian law of 14.08.1987] template name: data items for nursing file data elements Care of hygiene Care of mobility Care of elimination Care of food Food by probe Specific care of the mouth Handling emotional problem Care for disorientated patient... Vital parameter registration Physical parameter registration Physical parameter registration Surveillance of tractions, plasters Surveillance of tractions, plasters Withdrawal of blood Withdrawal of blood Administration of medications Administration of medications Surveillance of drips Surveillance of drips Care for closed wound Care for closed wound Care for open wound Care for open wound

29. option 8: Z segments Where is the limit ? Why clinical templates cannot extend to whole messages and Z-segments ? Registration and harmonisation = appropriate control by HL7 over the Z-segments (and over the list of allowed data elements) large benefits to the whole HL7 community

30. why templates ? purposes and use cases

31. typology of templates1/2 typology of templates1/2 1.USAM tables e.g. role-link-rolee.g. role-link-role 2.ENCAPSULATION (terminology vs RIM) e.g. to describe style in messagese.g. to describe style in messages 3.BATTERY = set of Acts sets of observations (i.e. battery)sets of observations (i.e. battery) (precise description for orders and payments) goals, outcomesgoals, outcomes sets of procedures (e.g. clinical guidelines)sets of procedures (e.g. clinical guidelines) data sets (e.g. from regulatory agencies)data sets (e.g. from regulatory agencies)

32. typology of templates2/2 typology of templates2/2 4.CDA-L2 = set of sections Clinical Document Architecture - level 2Clinical Document Architecture - level 2 expected shape of a documentexpected shape of a document 5.DICOM SR = set of sections, acts, materials, devices, … 6.MESSAGES = profiles, new messages ? internal needs of an organizationinternal needs of an organization needs of a specialty (e.g. cancer network)needs of a specialty (e.g. cancer network) needs of agencies (e.g. Public Health reporting)needs of agencies (e.g. Public Health reporting) needs of a region / country (e.g. xDT Germany)needs of a region / country (e.g. xDT Germany)

33. Expressing constraints on the RIM [from Usam manual, version 2.6, May 2000 (table 17) ] template: action with admitted relationships action –has precondition precondition in criteria mood precondition in criteria mood –has trigger trigger in criteria mood trigger in criteria mood –has contraindication contraindication contraindication –…

34. Style guidelines a) Representation using Value Name style: name is generic, values are elements of a list HLA Antigen found = {Aw43, B27, Cw1, Dw12,...} b) Representation using Variable Name style: list of all names, values are boolean HLA Aw43 Antigen = {Present, Absent} HLA B27 Antigen = {Present, Absent} … Both styles are in use: which one should be preferred ? clinical templates = guidelines for style ?

35. guidelines of practice define local or common practice rules [example from HL7 v2.x] Routine admission tests might containRoutine admission tests might contain –CBC, –Electrolytes –SMA12 –Urinalysis (Note that the elements of a battery for our purposes may also be batteries). (Note that the elements of a battery for our purposes may also be batteries).

36. NO - automatic filling in of defaults [from The Berkshire Eagle, May 23, 2000] template: normal liver A GP was discovered to use templates for the most frequent normal situations, to automatically fill in a list of detailed default values as if he was actually making each individual observation this is not our meaning of clinical template

37. cluster in ENV 13606 CLUSTER: "original component complex used to aggregate data items and/or other clusters to represent a compound concept. EXAMPLES. A blood pressure measurement consisting of systolic and diastolic pressure, a collection or closely related clinical findings, results of a battery of laboratory investigations, a treatment schedule consisting of several individually specified preparations or dosages. (cont.)

38. cluster in ENV 13606 a set of closely inter-related symptoms (e.g. a cough productive of discoloured sputum and blood); a single act of physical examination which generates more than one value (e.g. heart sounds, a blood pressure taken lying and standing); a set of quantities constituting a single test (e.g. a differential white cell count); a set of entries that might often be represented in a table (e.g. auditory evoked potentials); a single healthcare action that had two or more purposes or consequences. that had two or more purposes or consequences.

39. weak vs strong templates weak templates (organisers) to organize information e.g. subsections of a clinical document see also headed sections in ENV 13606 (EHCR - healthcare record) strong templates (bundles) to handle reusable aggregations e.g set of structured data elements see also clusters in ENV 13606

40. organisers Organisers are defined by their name only. They contain at least one organiser or one textual data element (and bundles) Organisers provide a weak context to their content. They provoke expectations in the human users. They convey authors perspective on data. The expected content of an organiser (e.g. the internal structure of a document) may be predefined to guide users

41. bundles Bundles are defined by their content. They identify a set of closely related items with a bottom-up process. They represent complex conceptual units. They contain only bundles and/or structured data elements (i.e. coded or quantitative data elements). Bundles provide a strong context to their content. They set a scope for their components. Clusters are usually predefined.

42. structured item name range bundle organiser textual item name text quantitative item name interval with units coded item name value domain

43. sharing templates need for registries ?

44. emerging needs in HL7 ? refine standard messages and documents with local detailed constraints or refinements, e.g. to satisfy the needs of –sub-communities (diabetes, cancer, ESRD) –ad-hoc information flows (e.g. CDC, HCFA) –regional or national information flows management of pathology networksmanagement of pathology networks registries, clinical trials, sharing records secondary usessecondary uses reporting to authorities, statistics

45. clinical templates: a real need ? is there a need to reduce combinatorial alternatives and impose a common style ? what is better achieved by a-posteriori transformations ? is there a need for control over the process through registration and support databases ? (i.e. decentralise but avoid the chaos) if communication is local, why HL7 should introduce international rules or registries ?

46. my vision: need for registries if we want to share clinical templates across organizations, components of templates must be registered. all names and labels used in templates 1.should be stored in a registry 2.should be mapped to the RIM classes 3.should have a well defined value set (how can we decentralize the register ?)

47. 3 pillars for real interoperability The optimal strategy is based on 3 pillars: 1. data dictionaries and metadata registries, including appropriate LOINC codes 2. clinical templates 3. tables with enumerated value domains they are complementary all 3 pillars are needed to assure a real semantic interoperability

48. 1. Metadata registries1/2 A registry of data elements, between one thousand robust data elements i.e. the attributes in the RIMone thousand robust data elements i.e. the attributes in the RIM millions of user-created XML labelsmillions of user-created XML labels Specializations of the RIM: each data element should be explicitly registered as a child/refinement of a RIM class, under control of the respective HL7-TC

49. 1. Metadata registries 2/2 Quick solution: Collection of data sets and lists of XML tags with either answer-list or ranges of values (e.g. see names for observations in LOINC; see also xDT/Germany, ASTM E1384) Optimal solution: Integrated repository (e.g. ISO 11179) with uniform and comparative representation of data elements from all the sources

50. 2. Clinical templates to aggregate data elements from the repository (including the RIM) into meaningful fragments i.e. building blocks, from predefined data elements, to produce more detailed messages, between hundreds of balloted standard messageshundreds of balloted standard messages millions of user-created DTD/schemasmillions of user-created DTD/schemas Templates (and the related data elements) need a process for (local) registration under the control of HL7 TCs a neutral language to represent templates ?

51. 3. Value domains Thousands of explicit tables with enumerated value domains or numeric ranges admitted values for each data element in the context of a clinical template "terminologies in context" coordinated by HL7 vocabulary TC (see the context groups in DICOM-SR)

52. HL7 light ? Open HL7 ? a registration process in addition to normal ballots

53. HL7 light ? fix by ballot the common framework (ISO ?), i.e. –basic rules and development processes –RIM and common templates –rules for registration my vision: two different speeds + legacy 1.ballot the general standards (as usual) 2.control decentralisation of detail –a registration process driven by HL7 users 3. legacy systems (Z-segment and adaptations)

54. 1. Unified development process Uniform process, according to HDF (HL7, CEN) the development framework allows to define the standard for a type of messages/documents –uniform measures for a vendor (level 7 !) to create, transport, parse, and visualize the instances of messages and documents general methodsgeneral methods same softwaresame software common skillscommon skills basic manuals and trainingbasic manuals and training

55. 2. Sharing pre-defined building blocks 1. usual ballots in HL7 (RIM, messages, CMETs) –the RIM (and the CEN-RIM) –general-purpose messages –basic clinical templates and CMETs 2. HL7 Committees register data elements and shared clinical templates (LOINC + ?) –data elements registered wrt the RIM –related value domains –useful clinical templates

56. ( Not just a list … ) harmonise data elements / XML tags across different systems/organisationsharmonise data elements / XML tags across different systems/organisations facilitate users feedback into the process by uniform collection of legacy usagesfacilitate users feedback into the process by uniform collection of legacy usages facilitate mapping from legacy data elements of end-users to registered data elements [similarly to RELMA for LOINC]facilitate mapping from legacy data elements of end-users to registered data elements [similarly to RELMA for LOINC]

57. 3. Decentralise detailed content HL7 members register "local" clinical templates define the content of their typical messages and documents (i.e. all and only the detailed data elements needed and adequate for a task) –National affiliates (and CEN/TC251 ?) –US government agencies –disease networks (e.g. cancer registries, ESRD) –member organisations –professional bodies

58. the new SIG a forum for discussion and harmonization

59. A new SIG on Clinical Templates to coordinate discussion across TC/SIGs and with external bodies CEN, ASTM, DICOM, GEHR.org,...CEN, ASTM, DICOM, GEHR.org,... XML schemas, bizTalk, ebXML, …XML schemas, bizTalk, ebXML, … compare perspectives on: – real needs – use cases, purposes, target groups – potential solutions no production activities within the template SIG

60. which HL7 group is involved ?1/3 most HL7 groups are already dealing with some template-like ideas. In my understanding: Modeling and Methodology (generalisation of the HL7 Development Framework) Government Projects SIG (data sets and messages controlled by Agencies, e.g. HCFA and CDC) (cont.)

61. which HL7 group is involved ?2/3 Image Management SIG (see DICOM Templates) Orders and Observation TC (formalisation of constraints described by narrative in the USAM document, aggregates of entries as batteries) Patient Care TC (definition of clinically meaningful aggregates, e.g. goals) (cont.)

62. which HL7 group is involved ?3/3 Clinical Decision Support and Arden Syntax TC (protocols and structures for decision making) Structured Document TC (organisers and structured containers) XML SIG (relation with XML schemas, registries of XML labels) Vocabulary TC (overlap with compositional systems, tables of value domains)

63. a forum for discussion1/2 Which mechanism can remain local ?Which mechanism can remain local ? Which mechanism should be regulated ?Which mechanism should be regulated ? Is order of components relevant ?Is order of components relevant ? And relationships among components ?And relationships among components ? Registration process or balloting ?Registration process or balloting ? –who will manage the register ? –what should be centralized ? How to include clinical templatesHow to include clinical templates in the whole HDF development framework ?

64. a forum for discussion2/2 how do we ensure that a registered template is unique ?how do we ensure that a registered template is unique ? how do we manage the process of creation, review, and approval ?how do we manage the process of creation, review, and approval ? what about customization/adaptations ?what about customization/adaptations ? how can we support concurrent content developers ?how can we support concurrent content developers ? how can we coordinate across different professional groups that may want to participate ?how can we coordinate across different professional groups that may want to participate ?

65. role of HL7 groups vs templates SIG The SIG is made of members from other groups each TC/SIG should produce its vision real user needs, use cases, kind of templates, examples and the future production activities. Role of the new SIG: clarify the perspective of each groupclarify the perspective of each group discover similarities and differencesdiscover similarities and differences comparative review of TCs visionscomparative review of TCs visions strategic proposals to the HL7 Boardstrategic proposals to the HL7 Board

66. who has a real need for templates ? e.g. professional societies (see cardiologists in DICOM …) quality of reports (check list) (complete, understandable, processable) clinical databases uniform data collection (clinical trials, clinical registries) are they aware ? what is the limit of promotion ?

67. perceived by professional groups ? groups that are currently working on clinical data sets include: DEEDS (CDC)DEEDS (CDC) Am. Dental AssociationAm. Dental Association Am. Ophtalmology AssociationAm. Ophtalmology Association Am. Coll. Obstetrics and GynecologyAm. Coll. Obstetrics and Gynecology Am. College of PediatricsAm. College of Pediatrics (consistent structure across specialties would be in the best interest of medicine)

68. filling in the gap clinical templates as a keyword: everything filling in the gap between (slow) ballot-based process(slow) ballot-based process Z-segments and local adaptationsZ-segments and local adaptations including registry of data elements (LOINC+) and related vocabularies now that XML is available we dont need HL7 anymore, right ? we dont need HL7 anymore, right ?

69. Issues what is a clinical template ? batteries, reusable fragments of messages, data sets, messages, internal structure of documents 3 pillars for semantic interoperability repositories, templates, value domains HL7 light ? –decentralisation of a registration process –neutral representation of templates –involvement of professionals and agencies concrete needs, use cases, solutions volunteers to prepare the January meeting