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Clinical templates, Clinical templates, registries registries and e-terminologies and e-terminologies from paper-based terminology from paper-based terminology systems to systems to semantic semantic interoperability interoperability Angelo Rossi Mori Angelo Rossi Mori National Research Council, Rome - National Research Council, Rome - Italy Italy HL7 / Vocabulary TC & CEN / TC251 HL7 / Vocabulary TC & CEN / TC251 / WG II / WG II

Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

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Page 1: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

Clinical templates, registriesClinical templates, registries

and e-terminologiesand e-terminologies

from paper-based terminology systems tofrom paper-based terminology systems to

semantic interoperabilitysemantic interoperability

Angelo Rossi MoriAngelo Rossi MoriNational Research Council, Rome - ItalyNational Research Council, Rome - Italy

HL7 / Vocabulary TC & CEN / TC251 / WG IIHL7 / Vocabulary TC & CEN / TC251 / WG II

Page 2: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

ContentsContents

• key requisites for e-terminologieskey requisites for e-terminologiesnew roles for e-terminologiesnew roles for e-terminologies

• 4 kinds of e-terminologies4 kinds of e-terminologiesusages, topics, actorsusages, topics, actors

• 3 pillars for semantic interoperability3 pillars for semantic interoperability(repositories, templates, value domains)(repositories, templates, value domains)

Page 3: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

Key requisites for e-terminologiesKey requisites for e-terminologies

• support support multiple usagesmultiple usages of clinical data of clinical data within information systemswithin information systems

• build build coherentcoherent "families”, each made of "families”, each made of many many specialisedspecialised coding schemes coding schemes

• restore restore continuumcontinuum between between contentcontent (values) and (values) and containerscontainers (data elements) (data elements)

• achieve achieve complete interoperabilitycomplete interoperability among applicationsamong applications

Page 4: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

Co-existence and specialisationCo-existence and specialisation

• co-existenceco-existence of families of coding schemes of families of coding schemeswithin the same information systemwithin the same information system(each scheme is conceived to satisfy a purpose)(each scheme is conceived to satisfy a purpose)

• specialised coding schemes differspecialised coding schemes differ– by amount of detailsby amount of details

(e.g. classification vs nomenclature)(e.g. classification vs nomenclature)– by kind of detailsby kind of details

(e.g. classifications with various purposes)(e.g. classifications with various purposes)

Page 5: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

Specialisation of coding schemesSpecialisation of coding schemes

• each coding scheme is conceived each coding scheme is conceived for a precise purpose and context:for a precise purpose and context:– 4-digit ICD 4-digit ICD statisticsstatistics– LOINC LOINC orders / prescriptionsorders / prescriptions– SNOMED SNOMED clinical detailclinical detail– CTP4 CTP4 claims / reimboursementclaims / reimboursement– MeSH MeSH information retrievalinformation retrieval– ......

Page 6: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

3 levels of clinical expressions3 levels of clinical expressions

the same data should be representedthe same data should be representedby the appropriate systemby the appropriate systemaccording to the actual task and purposeaccording to the actual task and purpose• unconstrained, spontaneous textunconstrained, spontaneous text

(it could be either dictated or typed text, or (it could be either dictated or typed text, or an entry from a predefined local vocabulary)an entry from a predefined local vocabulary)

• entry of a detailed nomenclatureentry of a detailed nomenclature

• class (grouping conceived for a purpose)class (grouping conceived for a purpose)

Page 7: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

clinical expressions in contextclinical expressions in contexttask terminological phrase

admission operation for lower third rectum cancer

scheduling abdominoperineal amputation of rectum

reporting low anterior resection of rectum with double stapling technique

discharge other anterior resection of rectum, ICD-9-CM 48.63

reimbours. operation for rectum cancer, DRG 147

cost anterior resection of the rectum analysis with double stapling technique

quality low anterior resection of rectum without temporary assurance colostomy and operation for lower third rectum cancer

Page 8: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

Different but coherent Different but coherent

• coherencecoherence among coding schemesamong coding schemes– unnecessary diversity shall be removedunnecessary diversity shall be removed– motivated diversity shall be fixedmotivated diversity shall be fixed

• coherence between coherence between – local expressionslocal expressions for "private" recording, and for "private" recording, and – "public" expressions"public" expressions for communication for communication

and comparisonsand comparisons

Page 9: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

Representing a statement / factRepresenting a statement / fact

• huge pre-coordinated nomenclaturehuge pre-coordinated nomenclature• combinatorial nomenclaturecombinatorial nomenclature

with controlled post-coordination (one code)with controlled post-coordination (one code)• multi-axial nomenclature — without rules multi-axial nomenclature — without rules

to produce combined expressions and codesto produce combined expressions and codes(repeat multiple values in one field)(repeat multiple values in one field)

• independent value domains independent value domains for a set of related data elements for a set of related data elements (clinical template arranging multiple fields)(clinical template arranging multiple fields)

Page 10: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

New roles of e-terminologyNew roles of e-terminology

• NO MORE "just labels"NO MORE "just labels"operational perspectiveoperational perspective of (clinical) data of (clinical) data

• key for retrieval of operative datakey for retrieval of operative datafrom from master tablesmaster tables and and knowledge basesknowledge bases– internal tables, within applicationsinternal tables, within applications– commercial drug databasescommercial drug databases– triggers, e.g. warnings and alarmstriggers, e.g. warnings and alarms– Arden syntax, MLM and decision supportArden syntax, MLM and decision support– ......

Page 11: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

ContentsContents

• key requisites for e-terminologieskey requisites for e-terminologiesnew roles for e-terminologiesnew roles for e-terminologies

• 4 kinds of e-terminologies4 kinds of e-terminologiesusages, topics, actorsusages, topics, actors

• 3 pillars for semantic interoperability3 pillars for semantic interoperability(repositories, templates, value domains)(repositories, templates, value domains)

Page 12: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

Usages, topics, actors - 1Usages, topics, actors - 1

• triggers for services within applicationstriggers for services within applications– life-cycle states (messages, workflows, activities)life-cycle states (messages, workflows, activities)– names of messages and segmentsnames of messages and segments

system developerssystem developersHL7 maintains closed tables - CNEHL7 maintains closed tables - CNE

• organisational & administrative parametersorganisational & administrative parameters– sex, race, religion, dietary preferencessex, race, religion, dietary preferences

facility managersfacility managersHL7 maintains reference tables - CWEHL7 maintains reference tables - CWE

Page 13: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

Usages, topics, actors - 2Usages, topics, actors - 2

• clinical / clinical / communicationcommunication & scheduling & scheduling– lab tests, document names, activity nameslab tests, document names, activity names

master tables builders & usersmaster tables builders & usersHL7 endorses adequate domainsHL7 endorses adequate domains

• clinical / recordingclinical / recording– findings, History & Physical, findings, History & Physical, – assessments, diagnoses, health issues assessments, diagnoses, health issues

recording professionalsrecording professionalsHL7 registers compatible domainsHL7 registers compatible domains

Page 14: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

ContentsContents

• key requisites for e-terminologieskey requisites for e-terminologiesnew roles for e-terminologiesnew roles for e-terminologies

• 4 kinds of e-terminologies4 kinds of e-terminologiesusages, topics, actorsusages, topics, actors

• 3 pillars for semantic interoperability3 pillars for semantic interoperability(repositories, templates, value domains)(repositories, templates, value domains)

Page 15: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

The emerging needsThe emerging needs

• satisfy needs of satisfy needs of – sub-communities (diabetes, cancer, ESRD)sub-communities (diabetes, cancer, ESRD)– ad-hoc information flows (e.g. CDC, HCFA)ad-hoc information flows (e.g. CDC, HCFA)

• assure more flexibility of messages assure more flexibility of messages and documentsand documents

• maintain maintain controlcontrol over the process over the processthrough through registrationregistration and and support databasessupport databasesi.e. decentralise but avoid the chaosi.e. decentralise but avoid the chaos

achieve “semantic interoperability”achieve “semantic interoperability”

Page 16: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

3 pillars for real interoperability3 pillars for real interoperability

The emerging strategy is based on 3 pillars:The emerging strategy is based on 3 pillars:

1. data dictionaries and metadata registries,1. data dictionaries and metadata registries,

including names of observations (LOINC)including names of observations (LOINC)

2. clinical templates2. clinical templates

3. tables with enumerated value domains3. tables with enumerated value domains

unresolved issue: unresolved issue: how to maintain the respective databases ?how to maintain the respective databases ?

Page 17: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

1. metadata registries1. metadata registries

• Simple list of data elementsSimple list of data elementswith either answer-list or ranges of valueswith either answer-list or ranges of values(e.g. see “names for observations” in LOINC;(e.g. see “names for observations” in LOINC;see also XDT/Germany, ISO 11179, ASTM E1384)see also XDT/Germany, ISO 11179, ASTM E1384)

• Integrated repositoryIntegrated repositorywith uniform representation of data elements with uniform representation of data elements

Extension of the RIM:Extension of the RIM:each data element should be explicitly each data element should be explicitly registered as a child / refinement of a RIM class,registered as a child / refinement of a RIM class,under control of the respective HL7-TCunder control of the respective HL7-TC

Page 18: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

RIM attribute

locally registered entry

HL7 registered entry

elementary entry

Page 19: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

we will need further stepswe will need further steps

• harmonise data elements and tables across different systems/organisations

• facilitate assignment of actual data elements of end-users to data elements adopted by secondary users(CDC, HCFA, …)

• facilitate feedback from end-users to secondary users

Page 20: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

2. clinical templates2. clinical templates

to aggregate data elements from the repositoryto aggregate data elements from the repository(or from the RIM) into meaningful fragments (or from the RIM) into meaningful fragments

i.e. building blocks i.e. building blocks

to allow for flexible messagesto allow for flexible messages

aggregates (and the related data elements)aggregates (and the related data elements)

need a registration processneed a registration process

under the control of HL7 TCs under the control of HL7 TCs

Page 21: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

examples of aggregatesexamples of aggregates

• batteries of lab testsbatteries of lab tests• blood pressure (systolic+diastolic)blood pressure (systolic+diastolic)

+ circumstances (patient's position, device)+ circumstances (patient's position, device)• pathways in USAM-RIM (mood+links table)pathways in USAM-RIM (mood+links table)

• DICOM-SR (templates + context groups) DICOM-SR (templates + context groups) • clusters in ENV 13606-2 clusters in ENV 13606-2 • clinical templates in HL7clinical templates in HL7• CMET in the HL7 HMD ?CMET in the HL7 HMD ?

Page 22: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

a potential clinical examplea potential clinical exampletemplate name:template name: “description of duodenoscopy” “description of duodenoscopy”

data elementdata element value domain (for duodenoscopy) value domain (for duodenoscopy)

lumenlumen {normal, spasm, stenosis, …}{normal, spasm, stenosis, …}contentscontents {blood, biliary stones, parasites, …}{blood, biliary stones, parasites, …}wallwall {rigid, decreased distensibility, …}{rigid, decreased distensibility, …}mucosamucosa {atrophic, granular, hyperemic, …}{atrophic, granular, hyperemic, …}hemorrhagehemorrhage {mucosal bleeding, varices, …}{mucosal bleeding, varices, …}flat lesionsflat lesions {aphta, infiltration, …}{aphta, infiltration, …}protrusionsprotrusions {papule, polyp, …}{papule, polyp, …}…… ... ...

(from “Nomenclature of Digestive Endoscopy”, OMED, 1994)(from “Nomenclature of Digestive Endoscopy”, OMED, 1994)

Page 23: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

Example of legal requirementsExample of legal requirementstemplate name:template name: “data items for nursing file” “data items for nursing file”

data elementsdata 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 • ...

(Belgian law of 14.08.1987)

• Vital parameter registration • Physical parameter registration • Surveillance of tractions, plasters• Withdrawal of blood • Administration of medications • Surveillance of drips • Care for closed wound • Care for open wound

Page 24: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

repository entry

clinical templateelementary entry

Page 25: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

3. Value domains3. Value domains

Hundreds of explicit tables Hundreds of explicit tables

with enumerated value domainswith enumerated value domainsadmitted values for each data element admitted values for each data element

of the RIM and of the repository,of the RIM and of the repository,

considering restrictions due to clinical templatesconsidering restrictions due to clinical templates

"e-terminologies in context" "e-terminologies in context" coordinated by HL7 vocabulary TCcoordinated by HL7 vocabulary TC

Page 26: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

numeric range

HL vocab entry

value domain

elementary entry

has domain is restriction of

enumerated table

HL7 table external reference

Page 27: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

a Cluster in CEN 13606-2

"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.”

Page 28: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

kinds of Clusters (CEN 13606-2)

• 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.

Page 29: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

battery in HL7 1/4

“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.

Page 30: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

battery in HL7 2/4"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). "

Page 31: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

battery in HL7 3/4

"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.

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. "

Page 32: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

battery in HL7 4/4

"The word battery is used in this specification synonymously with the word 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.”

Page 33: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

structure of a Template 1/2GLOBAL INFORMATION- global name of the template (with code)- global interpretation or score- global purpose / criterion for aggregation- parent template (and kind of refinement)- global circumstances for the template as a whole

(e.g. features of the sample, position of patient)

- either pre-defined (e.g. type of sample, device)

- or as slot to be instantiated (e.g. date of sampling)

- common parameters that apply to each member, - either fixed (e.g. units) or variable

Page 34: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

structure of a Template 2/2

INFORMATION ON MEMBERS of the template

(they can be other templates)

• complete name of member, with code (from an agreed pre-existing coding system)

• value of the member (with units, if relevant)• parameters that will assume a different value for

each member (e.g. time of sampling for each value of a glucose tolerance test)

Page 35: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

3-speed standard process

1. usual ballot in HL7

2. registration of data elements and CMETs

(and messages/docs) by Committee

3. registration of CMETs (and messages/docs) by– national affiliates– government agencies– disease networks (e.g. cancer registries, ESRD)– member organisations

Page 36: Clinical templates, registries and e-terminologies from paper-based terminology systems to semantic interoperability Angelo Rossi Mori National Research

3 components of messages/docs

• data elements (+ definitions, value domains)from RIM or from a data dictionary

• arrangements into a message/document(+parsing rules and tools)i.e. developed according to HMD

• "quality", i.e. adequacy to task(all and only the needed data elements),assured by ballot or registration