clinical templates, registries and terminologies

Clinical templates, Clinical templates,

registries and terminologiesregistries and terminologies

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

HL7 / Clinical Templates SIG & CEN / TC251 / WG IIHL7 / Clinical Templates SIG & CEN / TC251 / WG II

ContentsContents

what is a clinical template ?what is a clinical template ?batteries, data sets, batteries, data sets, reusable fragments of messagesreusable fragments of messages

3 pillars for semantic interoperability3 pillars for semantic interoperabilityrepositories, templates, value domainsrepositories, templates, value domains

““HL7 light”: a complementary approachHL7 light”: a complementary approach– decentralisation of a registration processdecentralisation of a registration process– involvement of professionals and agenciesinvolvement of professionals and agencies– a common strategy for HL7 and CEN ?a common strategy for HL7 and CEN ?

what is a template ?

too many legitimate

perspectives and options

batterybattery in HL7 in HL7 1/51/5

““battery:battery: a set of one or more observations a set of one or more observations identified as by a single name and code number, identified as by a single name and code number, and treated as a shorthand unit and treated as a shorthand unit for ordering or retrieving results for ordering or retrieving results of the constituent observations. …of the constituent observations. …

Vital signs, electrolytes, routine admission tests, Vital signs, electrolytes, routine admission tests, and obstetrical ultrasound are all examples.”and obstetrical ultrasound are all examples.”


""Vital signsVital signs (conventionally) consist of (conventionally) consist of diastolic and systolic blood pressure, diastolic and systolic blood pressure, pulse, and respiratory rate. pulse, and respiratory rate.

ElectrolytesElectrolytes usually consist of usually consist of Na+, K+, Cl-, and HCO3-.Na+, K+, Cl-, and HCO3-.

Routine admission testsRoutine admission tests might contain might contain CBC, Electrolytes, SMA12, and Urinalysis. CBC, Electrolytes, SMA12, and Urinalysis. (Note that the elements of a battery (Note that the elements of a battery for our purposes may also be batteries).for our purposes may also be batteries). " "


""Obstetrical ultrasoundObstetrical ultrasound is a battery is a battery made up of made up of traditional component measurementstraditional component measurementsand the impression, and the impression, all of which would be returned all of which would be returned as separate results as separate results when returned to the requestor. "when returned to the requestor. "


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


"The word battery is used in this specification"The word battery is used in this specificationsynonymously with the words synonymously with the words profileprofile or or panelpanel. .

The individual observation elements The individual observation elements within a battery may be within a battery may be characteristic of a physiologic system characteristic of a physiologic system (e.g., liver function tests), (e.g., liver function tests), or many different physiologic systems.”or many different physiologic systems.”

Crucial issuesCrucial issues

Version 2.x provides no rules Version 2.x provides no rules for for harmonizationharmonization / / registrationregistration of batteries of batteries

Constituent elements of a batteryConstituent elements of a batterymust be predefinedmust be predefined

– Need for a registry of data elementsNeed for a registry of data elements

– Need for computable value domainsNeed for computable value domains(numeric ranges, code sets)(numeric ranges, code sets)

Example on Lab Data resultsExample on Lab Data results

[from HL7 version 2, § 7.4.3][from HL7 version 2, § 7.4.3]

OBROBR|1|870930010^OE|CM3562^LAB| |1|870930010^OE|CM3562^LAB| 8000480004^̂ELECTROLYTESELECTROLYTES|…|…

OBXOBX|1|ST|84295^|1|ST|84295^NANA||||150150||mmol/l|136-148|mmol/l|136-148|......OBXOBX|2|ST|84132^|2|ST|84132^K+K+||||4.54.5||mmol/l|3.5-5|mmol/l|3.5-5|......OBXOBX|3|ST|82435^|3|ST|82435^CLCL||||102102||mmol/l|94-105|mmol/l|94-105|......OBXOBX|4|ST|82374^|4|ST|82374^CO2CO2||||2727||mmol/l|24-31|…mmol/l|24-31|…

Option 1: master tablesOption 1: master tables

the content of the "electrolytes“ template the content of the "electrolytes“ template is a set of 4 OBXsis a set of 4 OBXswith locally predefined names and units.with locally predefined names and units.For example, stored in Master TablesFor example, stored in Master TablesOnly the template name is sent in the orderOnly the template name is sent in the order

Numeric valuesNumeric values will be filled in at the instantiationwill be filled in at the instantiation

How can we harmonize definitionsHow can we harmonize definitionsacross master tables of different organizations ?across master tables of different organizations ?

negotiating the templatenegotiating the template

the master table approach involvesthe master table approach involves

a negotiation between sender and receivera 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 ?- how to assure version identification ?

- is it safe to send only the template name in - is it safe to send only the template name in an order, without the detail on content ? an order, without the detail on content ?

NEW: panel names in LOINCNEW: panel names in LOINC

[from LOINC, vers. June 2000, at [from LOINC, vers. June 2000, at www.regenstrief.org/loincwww.regenstrief.org/loinc]]

hemogram panelhemogram panel (code=24358-4)(code=24358-4)

panel elements = panel elements = ““erythrocytes; leukocytes; hematocrit; erythrocytes; leukocytes; hematocrit; hemoglobin; MCV; MCH; MCHC; RDWhemoglobin; MCV; MCH; MCHC; RDW””

hemogram & platelets panel hemogram & platelets panel (code=24317-0)(code=24317-0)

panel elements = panel elements = ““hemogram panel; platelets; MPVhemogram panel; platelets; MPV””

option 2: LOINC+ as registeroption 2: LOINC+ as register

• first 51 panels are availablefirst 51 panels are available• fast and reactive maintenance process fast and reactive maintenance process

LOINC could be a good source LOINC could be a good source for names and codes of templatesfor names and codes of templates

but but description of contentdescription of content is text-based, i.e. is text-based, i.e.– ranges are not computer-processable ranges are not computer-processable – value sets do not use LOINC codesvalue sets do not use LOINC codes

is the description “is the description “definingdefining” the template ?” the template ?which change justifies a new template ?which change justifies a new template ?

Example on Medical RecordExample on Medical Record in HL7in HL7

[from HL7 version 2, § 9.6][from HL7 version 2, § 9.6]

TXATXA|0001||0001|HP^history & physicalHP^history & physical|TX^text| … |TX^text| …

OBXOBX|1|CE|2000.40^|1|CE|2000.40^CHIEF COMPLAINTCHIEF COMPLAINT|| ... || ...

OBXOBX|2|ST|2000.01^|2|ST|2000.01^SOURCESOURCE||PATIENT||PATIENT ... ...

OBXOBX|3|TX|2000.02^|3|TX|2000.02^PRESENT ILLNESSPRESENT ILLNESS| |SUDDEN | |SUDDEN ONSET OF CHEST PAIN. 2 DAYS, PTA ONSET OF CHEST PAIN. 2 DAYS, PTA ASSOCIATED WITH NAUSEA, VOMITING & SOB. ASSOCIATED WITH NAUSEA, VOMITING & SOB. NO RELIEF WITH ANTACIDS … NO RELIEF WITH ANTACIDS …

option 3: set of detailed standardsoption 3: set of detailed standards

CHIEF COMPLAINTCHIEF COMPLAINT

SOURCESOURCE

PRESENT ILLNESSPRESENT ILLNESS

… … how to obtain wide consensus how to obtain wide consensus

on on section of documentssection of documents ? ?

see standardization initiatives in see standardization initiatives in

• ASTM 31.25 and ASTM 31.25 and

• Clinical Doc. Architecture level 2 (PRA)Clinical Doc. Architecture level 2 (PRA)

Systematic rules for compositionSystematic rules for composition

Template:Template: “systolic blood pressure” “systolic blood pressure” OBX for systolic BPOBX for systolic BPqualifiers: qualifiers:

– patient's positionpatient's position– devicedevice– measurement sitemeasurement site

the circumstances of the measurement could be:the circumstances of the measurement could be:• additional OBXs additional OBXs • coded elements in a compositional data typecoded elements in a compositional data type• detail within a “molecular code”detail within a “molecular code”

option 4: combinatorial codesoption 4: combinatorial codes

the observation code for systolic BP can be either the observation code for systolic BP can be either a single “molecular code” or a combination of codes ona single “molecular code” or a combination of codes on

– patient's positionpatient's position– devicedevice– measurement sitemeasurement site

We must control the overlap betweenWe must control the overlap betweenterminological component of observation codeterminological component of observation codeexplicit RIM attributesexplicit RIM attributes

(rules for combinatorial codes (rules for combinatorial codes are managed by are managed by coding system developerscoding system developers) )

recurring subsegmentsrecurring subsegments

[from ENV 12610, [from ENV 12610, Medicinal product identification,Medicinal product identification,Table 5.2.2 : Table 5.2.2 : Trade Trade medicinal product identifiers]medicinal product identifiers]

clinical template:clinical template:trade trade trade trade uniqueunique

contents:contents: group group namename trade IDtrade ID

4.2.14.2.1 medicinal product medicinal product designationdesignation x x x x x x

4.2.84.2.8 dosage formdosage form x x x x4.2.144.2.14 route of administrationroute of administration x x x x4.2.64.2.6 strengthstrength x x x x4.2.114.2.11 medicinal product medicinal product

batch numberbatch number x x

option 5: RMIM - CMEToption 5: RMIM - CMET

define new (local) templatesdefine new (local) templates

applying the same development methodologyapplying the same development methodology

conceived for standard messages in HL7 conceived for standard messages in HL7

• need for thousands of data elementsneed for thousands of data elements

as (local) extensions of the RIMas (local) extensions of the RIM

• need for a registry of templates ?need for a registry of templates ?

Schemas (e.g. BizTalk)Schemas (e.g. BizTalk)

[from the iEHR schema, by iSoft, at [from the iEHR schema, by iSoft, at www.biztalk.orgwww.biztalk.org]]

<ElementType name="<ElementType name="QuantifiableObsQuantifiableObs”” … … >><element type="<element type="MeasurableQuantityMeasurableQuantity"/>"/><element type="<element type="ResultAsNumberResultAsNumber"/>"/><element type="<element type="ResultAsRangeResultAsRange"/>"/><element type="<element type="ResultAsDateResultAsDate"/>"/><element type="<element type="ResultAsTextResultAsText"/>"/><element type="<element type="ReferenceLimitReferenceLimit"/>"/>

</ElementType></ElementType>

option 6: XML familyoption 6: XML family

1.1. define XML labelsdefine XML labels2.2. define their combination by measures “external”define their combination by measures “external”

to HL7 constructs (e.g. XML schemas ?) to HL7 constructs (e.g. XML schemas ?)

• in in Biztalk Biztalk (not limited to healthcare)(not limited to healthcare)::– meaning of labels and value sets are not described !meaning of labels and value sets are not described !– no comparison of XML tags from different vendors !no comparison of XML tags from different vendors !

• in in ebXMLebXML (not limited to healthcare) : (not limited to healthcare) :– registries ?registries ?

• a specific HL7 registry with a specific HL7 registry with XML.orgXML.org ? ?

Conditional templates 1/3Conditional templates 1/3

[from the CDC form for Hepatitis A notification][from the CDC form for Hepatitis A notification]

BASIS FOR DIAGNOSISBASIS FOR DIAGNOSISCLINICAL DATACLINICAL DATA

Symptomatic ? Symptomatic ? yes yes no no unknownunknownif yes,if yes, Onset date ____ Onset date ____

Diarrhea Diarrhea yes yes no no if yes,if yes, from ____ to ____from ____ to ____

Jaundiced Jaundiced yes yes no no HospitalizedHospitalized yes yes no no Died Died yes yes no no

LABORATORY TESTS ...LABORATORY TESTS ...


Diarrhea Diarrhea yes yes no no if yes,if yes, from ___ to ___from ___ to ___

Diarrhea is a finding, with boolean values.Diarrhea is a finding, with boolean values.The above structure could be generalised as:The above structure could be generalised as:

Template:Template: “boolean finding with dates” “boolean finding with dates”

booleanFinding^LOINC^code | booleanValuebooleanFinding^LOINC^code | booleanValueif booleanValue = “yes”if booleanValue = “yes”

– ““starting date”^LOINC^2345-7 | datestarting date”^LOINC^2345-7 | date– ““ending date”^LOINC^3456-8 | dateending date”^LOINC^3456-8 | date


Template:Template: “boolean finding with dates” “boolean finding with dates”booleanFinding^LOINC^code | booleanValuebooleanFinding^LOINC^code | booleanValueif booleanValue = ...if booleanValue = ...

Refinement of template:Refinement of template:

conditional block: “diarrhea with dates”conditional block: “diarrhea with dates”““diarrheadiarrhea”^LOINC^”^LOINC^1234-61234-6 | booleanValue | booleanValueif booleanValue = “yes”if booleanValue = “yes”

– ““starting date”^LOINC^2345-7 | datestarting date”^LOINC^2345-7 | date– ““ending date”^LOINC^3456-8 | dateending date”^LOINC^3456-8 | date

option 7: Arden syntaxoption 7: Arden syntax

• Arden syntax is the existing mechanism Arden syntax is the existing mechanism

for if-then rulesfor if-then rules

• it is harmonized with RIM and HDFit is harmonized with RIM and HDF

it could be extended for this purposeit could be extended for this purpose

(a special mechanism (a special mechanism

just for this kind of template …)just for this kind of template …)

Clinical check list ? Clinical check list ? ((… … DICOM )DICOM )

[from “Nomenclature of Digestive Endoscopy”, OMED 1994][from “Nomenclature of Digestive Endoscopy”, OMED 1994]

template name:template name: “description of duodenoscopy” “description of duodenoscopy”

data elementsdata elements 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, …}…… ... ...

Legal data sets ?Legal data sets ?

[from the Belgian law of 14.08.1987][from the Belgian law of 14.08.1987]

template name:template name: “data items for nursing file” “data items for nursing file”

data elementsdata elements Care of hygiene Care of hygiene Care of mobility Care of mobility Care of elimination Care of elimination Care of food Care of food Food by probe Food by probe Specific care of the mouth Specific care of the mouth Handling emotional problem Handling emotional problem Care for disorientated patient Care for disorientated patient ......

Vital parameter registration Vital parameter registration Physical parameter registration Physical parameter registration Surveillance of tractions, plastersSurveillance 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 woundCare for open wound

option 8: Z segmentsoption 8: Z segments

Where is the limit ?Where is the limit ? Why clinical templates cannot extend Why clinical templates cannot extend

to to whole messageswhole messages and and Z-segmentsZ-segments ? ?

Registration and harmonisationRegistration and harmonisation= = appropriate control by HL7appropriate control by HL7

over the Z-segmentsover the Z-segments(and over the list of allowed data elements)(and over the list of allowed data elements)

large benefits to the whole HL7 communitylarge benefits to the whole HL7 community

why templates ?

purposes and use cases

typology of templatestypology of templates 1/21/2

1.1. USAM tablesUSAM tables• e.g. role-link-rolee.g. role-link-role

2.2. ENCAPSULATION (terminology vs RIM)ENCAPSULATION (terminology vs RIM)• e.g. to describe style in messages e.g. to describe style in messages

3.3. BATTERY = set of “Acts” BATTERY = set of “Acts” • sets of observations (i.e. battery)sets of observations (i.e. battery)

(precise description for orders and payments)(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)

typology of templatestypology of templates 2/22/2

4.4. CDA-L2 = set of sectionsCDA-L2 = set of sections• Clinical Document Architecture - level 2Clinical Document Architecture - level 2• expected shape of a document expected shape of a document

5.5. DICOM SR = set of sections, acts, materials, devices, …DICOM SR = set of sections, acts, materials, devices, …

6.6. MESSAGES = profiles, new messages ?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)

Expressing constraints on the RIMExpressing constraints on the RIM

[from Usam manual, version 2.6, May 2000 (table 17) ][from Usam manual, version 2.6, May 2000 (table 17) ]

template: “template: “action with admitted relationships”action with admitted relationships”

action action – has preconditionhas precondition

• precondition precondition in criteria moodin criteria mood– has triggerhas trigger

• trigger trigger in criteria moodin criteria mood– has contraindicationhas contraindication

• contraindicationcontraindication– ……

Style guidelinesStyle guidelines

a) Representation using “a) Representation using “Value”Value” Name style: Name style:name is generic, values are elements of a listname is generic, values are elements of a list

HLA Antigen found = {Aw43, B27, Cw1, Dw12, ...}HLA Antigen found = {Aw43, B27, Cw1, Dw12, ...}

b) Representation using “b) Representation using “Variable”Variable” Name style: Name style:list of all names, values are booleanlist of all names, values are boolean

HLA Aw43 Antigen = {Present, Absent}HLA Aw43 Antigen = {Present, Absent}HLA B27 Antigen = {Present, Absent}HLA B27 Antigen = {Present, Absent}……

Both styles are in use: which one should be preferred ?Both styles are in use: which one should be preferred ?

clinical templates = guidelines for style ?clinical templates = guidelines for style ?

guidelines of practiceguidelines of practice

definedefine local or common practice rules local or common practice rules

[example from HL7 v2.x][example from HL7 v2.x]

““Routine admission testsRoutine admission tests might contain might contain – CBC, CBC, – ElectrolytesElectrolytes– SMA12 SMA12 – UrinalysisUrinalysis

(Note that the elements of a battery (Note that the elements of a battery

for our purposes may also be batteries).for our purposes may also be batteries).””

NO - automatic filling in of defaultsNO - automatic filling in of defaults

[from “The Berkshire Eagle”, May 23, 2000][from “The Berkshire Eagle”, May 23, 2000]

template: “template: “normal livernormal liver””A GP was discovered to use “templates”A GP was discovered to use “templates”for the most frequent “normal situations” ,for the most frequent “normal situations” ,to automatically fill into automatically fill ina a list of detailed default valueslist of detailed default values

as if he was actually making as if he was actually making each individual observationeach individual observation

this is not our meaning of clinical templatethis is not our meaning of clinical template

clustercluster in ENV 13606 in ENV 13606

CLUSTERCLUSTER:: "original component complex "original component complex used to aggregate used to aggregate data itemsdata items and/or other and/or other clustersclusters to represent a compound concept.to represent a compound concept.

EXAMPLES. EXAMPLES.

A A blood pressure measurementblood pressure measurement consisting consisting of systolic and diastolic pressure, of systolic and diastolic pressure,

a a collectioncollection or closely related or closely related clinical findingsclinical findings, ,

results of a results of a battery of laboratory investigationsbattery of laboratory investigations, ,

a a treatment scheduletreatment schedule consisting of several consisting of several individually specified preparations or dosages.”individually specified preparations or dosages.”

(cont.)(cont.)

clustercluster in ENV 13606 in ENV 13606

a a set of closely inter-related symptomsset of closely inter-related symptoms (e.g. a cough productive of discoloured sputum and blood);(e.g. a cough productive of discoloured sputum and blood);

a single act of a single act of physical examinationphysical examination which generates more than one value which generates more than one value (e.g. heart sounds, a blood pressure taken lying and standing);(e.g. heart sounds, a blood pressure taken lying and standing);

a set of quantities constituting a a set of quantities constituting a single testsingle test (e.g. a differential white cell count);(e.g. a differential white cell count);

a set of entries that might often be represented in a tablea set of entries that might often be represented in a table(e.g. auditory evoked potentials);(e.g. auditory evoked potentials);

a single healthcare actiona single healthcare action that had two or more purposes or consequences.that had two or more purposes or consequences.

weak vs strong templatesweak vs strong templates

weak templates (organisers) to organize informatione.g. subsections of a clinical documentsee also headed sections in ENV 13606 (EHCR - healthcare record)

strong templates (bundles)to handle reusable aggregationse.g set of structured data elements see also clusters in ENV 13606

organisersorganisers

Organisers are defined by their name only. Organisers are defined by their name only.

They contain at least one organiser or They contain at least one organiser or one textual data element (and bundles) one textual data element (and bundles)

Organisers provide a Organisers provide a weakweak context to their content. context to their content.They provoke expectations in the human users.They provoke expectations in the human users.They convey author’s perspective on data.They convey author’s perspective on data.

The expected content of an organiser The expected content of an organiser (e.g. the internal structure of a document)(e.g. the internal structure of a document)may be predefined to guide usersmay be predefined to guide users

bundlesbundles

Bundles are defined Bundles are defined by their content.by their content.They identify a set of closely related itemsThey identify a set of closely related itemswith a ”bottom-up” process.with a ”bottom-up” process.They represent complex conceptual units.They represent complex conceptual units.

They contain only bundles and/or They contain only bundles and/or ”structured” data elements ”structured” data elements (i.e. coded or quantitative data elements).(i.e. coded or quantitative data elements).

Bundles provide a Bundles provide a strongstrong context to their content. context to their content.They set a scope for their components.They set a scope for their components.

Clusters are usually predefined.Clusters are usually predefined.

structured itemnamerange

bundleorganiser

textual itemnametext

quantitative itemnameinterval with units

coded itemnamevalue domain

sharing templates

need for registries ?

emerging needs in HL7 ?emerging needs in HL7 ?

refine standard messages and documents refine standard messages and documents with “local” detailed constraints or refinements, with “local” detailed constraints or refinements, e.g. to satisfy the needs of e.g. to satisfy the 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)– regional or national information flowsregional or national information flows

• management of pathology networksmanagement of pathology networksregistries, clinical trials, sharing recordsregistries, clinical trials, sharing records

• secondary usessecondary usesreporting to authorities, statisticsreporting to authorities, statistics

clinical templates: a real need ?clinical templates: a real need ?

is there a need to reduce combinatorial alternatives is there a need to reduce combinatorial alternatives and and impose a common “style”impose a common “style” ? ?

what is better achieved by what is better achieved by a-posteriori transformations ?a-posteriori transformations ?

is there a need for is there a need for controlcontrol over the process over the processthrough through registrationregistration and and support databasessupport databases ? ?(i.e. decentralise but avoid the chaos)(i.e. decentralise but avoid the chaos)

if communication is local, why HL7 shouldif communication is local, why HL7 shouldintroduce introduce internationalinternational rules or registries rules or registries ? ?

my visionmy vision: need for registries: need for registries

if we want to share clinical templates if we want to share clinical templates across organizations,across organizations,components of templates must be registered.components of templates must be registered.

all names and labels used in templatesall names and labels used in templates1.1. should be stored in a registry should be stored in a registry 2.2. should be mapped to the RIM classesshould be mapped to the RIM classes3.3. should have a well defined “value set”should have a well defined “value set”

(how can we (how can we decentralizedecentralize the register ?) the register ?)

3 pillars for real interoperability3 pillars for real interoperability

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

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

including appropriate “LOINC codes”including appropriate “LOINC codes”

2. clinical templates2. clinical templates

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

they are complementarythey are complementary

all 3 pillars are needed to assure all 3 pillars are needed to assure a real a real semantic interoperabilitysemantic interoperability

1. Metadata registries1. Metadata registries 1/21/2

A registry of data elements, betweenA registry of data elements, between• one thousandone thousand robust data elements robust data elements

i.e. the attributes in the i.e. the attributes in the RIMRIM• millionsmillions of user-created of user-created XML labelsXML labels

Specializations of the RIM:Specializations 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

1. Metadata registries 1. Metadata registries 2/22/2

Quick solution:Quick solution:

Collection of data sets and lists of XML tagsCollection of data sets and lists of XML tagswith 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, ASTM E1384)see also xDT/Germany, ASTM E1384)

Optimal solution:Optimal solution:

Integrated repository Integrated repository (e.g. ISO 11179)(e.g. ISO 11179)with uniform and comparative representation with uniform and comparative representation of data elements from all the sourcesof data elements from all the sources

2. Clinical templates2. Clinical templates

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

i.e. building blocks, i.e. building blocks, from predefined data elementsfrom predefined data elements,,to produce more detailed messages, betweento produce more detailed messages, between• hundredshundreds of balloted of balloted standard messagesstandard messages• millionsmillions of user-created of user-created DTD/schemasDTD/schemas

Templates (and the related data elements)Templates (and the related data elements)need a process for (local) registration need a process for (local) registration under the control of HL7 TCs under the control of HL7 TCs

a neutral language to represent templates ?a neutral language to represent templates ?

3. Value domains3. Value domains

Thousands of explicit tables Thousands of explicit tables with enumerated value domainswith enumerated value domainsor numeric rangesor numeric ranges

admitted values for each data element admitted values for each data element in the context of a clinical templatein the context of a clinical template

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

(see the “context groups” in DICOM-SR) (see the “context groups” in DICOM-SR)

HL7 light ?Open HL7 ?

a registration process

in addition to normal ballots

““HL7 light” ?HL7 light” ?

fix by ballot the common framework (ISO ?), i.e.fix by ballot the common framework (ISO ?), i.e.– basic rules and development processesbasic rules and development processes– RIM and common templatesRIM and common templates– rules for registrationrules for registration

my vision: two different speeds + legacymy vision: two different speeds + legacy

1.1. ballot the general standards (as usual)ballot the general standards (as usual)2.2. control decentralisation of detailcontrol decentralisation of detail

– a registration process driven by HL7 usersa registration process driven by HL7 users3. legacy systems (Z-segment and adaptations)3. legacy systems (Z-segment and adaptations)

1. Unified development process1. Unified development process

Uniform process, according toUniform process, according to HDFHDF (HL7, CEN) (HL7, CEN)the development framework allows to define the development framework allows to define the standard for a type of messages/documentsthe standard for a type of messages/documents– uniform measures for a vendor (level 7 !) uniform measures for a vendor (level 7 !)

to create, transport, parse, and visualizeto create, transport, parse, and visualizethe the instancesinstances of messages and documents of messages and documents• general methodsgeneral methods• same softwaresame software• common skillscommon skills• basic manuals and trainingbasic manuals and training

2. Sharing pre-defined building blocks2. Sharing pre-defined building blocks

1. usual ballots in HL7 (RIM, messages, CMETs)1. usual ballots in HL7 (RIM, messages, CMETs)– the RIM (and the CEN-RIM)the RIM (and the CEN-RIM)– general-purpose messagesgeneral-purpose messages– basic clinical templates and CMETsbasic clinical templates and CMETs

2. HL7 Committees 2. HL7 Committees registerregister data elementsdata elements and “shared” clinical templates (LOINC + ?) and “shared” clinical templates (LOINC + ?)– data elements registered wrt the RIMdata elements registered wrt the RIM– related value domainsrelated value domains– useful clinical templatesuseful clinical templates

( Not just a list … )( Not just a list … )

• harmonise data elements / XML tags harmonise data elements / XML tags across different systems/organisationsacross different systems/organisations

• facilitate users’ feedbackfacilitate users’ feedback into the process into the process by uniform collection of legacy usages by uniform collection of legacy usages

• facilitate mappingfacilitate mapping from legacy data elements of end-users from legacy data elements of end-users to registered data elements to registered data elements [similarly to RELMA for LOINC][similarly to RELMA for LOINC]

3. Decentralise detailed content3. Decentralise detailed content

HL7 members HL7 members registerregister "local" clinical templates "local" clinical templates

define the content of define the content of theirtheir typical messages and typical messages and documents (i.e. documents (i.e. all and only the detailed all and only the detailed data elements needed and adequate for a taskdata elements needed and adequate for a task))– National affiliates (and CEN/TC251 ?)National affiliates (and CEN/TC251 ?)– US government agenciesUS government agencies– disease networks (e.g. cancer registries, ESRD)disease networks (e.g. cancer registries, ESRD)– member organisations member organisations – professional bodiesprofessional bodies

the new SIG

a forum for discussion

and harmonization

A new SIG on Clinical TemplatesA new SIG on Clinical Templates

to coordinate discussion across TC/SIGsto coordinate discussion across TC/SIGsand with external bodies 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:compare perspectives on:– real needsreal needs– use cases, purposes, target groupsuse cases, purposes, target groups– potential solutionspotential solutions

no production activities within the template SIGno production activities within the template SIG

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.)


• 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.)


• 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)

a forum for discussiona forum for discussion 1/21/2

• 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 ?who will manage the register ?– what should be centralized ?what should be centralized ?

• How to include clinical templates How to include clinical templates in the whole HDF development framework ?in the whole HDF development framework ?

a forum for discussiona forum for discussion 2/22/2

• how do we ensure that how do we ensure that a registered template is unique ?a registered template is unique ?

• how do we manage the process ofhow do we manage the process ofcreation, review, and approval ?creation, review, and approval ?

• what about customization/adaptations ?what about customization/adaptations ?• how can we support concurrenthow can we support concurrent

content developers ?content developers ?• how can we coordinate acrosshow can we coordinate across

different professional groupsdifferent professional groupsthat may want to participate ?that may want to participate ?

role of HL7 groups vs templates SIGrole of HL7 groups vs templates SIG

The SIG is made of members from other groupsThe SIG is made of members from other groups

each TC/SIG should produce its visioneach TC/SIG should produce its visionreal user needs, use cases, kind of templates,real user needs, use cases, kind of templates,examples and the future “production” activities.examples and the future “production” activities.

Role of the new SIG: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

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” ?

perceived by professional groups ?perceived by professional groups ?

groups that are currently workinggroups that are currently workingon on clinical data setsclinical data sets include: 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 (consistent structure across specialties would be in the best interest of medicine)would be in the best interest of medicine)

filling in the gapfilling in the gap

““clinical templates” as a keywordclinical templates” as a keyword::

everything filling in the gap betweeneverything 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+)including registry of data elements (LOINC+)and related vocabulariesand related vocabularies

““now that XML is available now that XML is available we don’t need HL7 anymore, right ?”we don’t need HL7 anymore, right ?”

IssuesIssues

what is a clinical template ?what is a clinical template ?batteries, reusable fragments of messages,batteries, reusable fragments of messages,data sets, messages, data sets, messages, internal structure of documentsinternal structure of documents

3 pillars for semantic interoperability3 pillars for semantic interoperabilityrepositories, templates, value domainsrepositories, templates, value domains

HL7 light ?HL7 light ?– decentralisation of a registration processdecentralisation of a registration process– neutral representation of templatesneutral representation of templates– involvement of professionals and agenciesinvolvement of professionals and agencies

concrete needs, use cases, solutionsconcrete needs, use cases, solutionsvolunteers to prepare the January meetingvolunteers to prepare the January meeting

clinical templates, registries and terminologies

Documents