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DataDefinition,DataCapture,QualityAssuranceandAdherencetoInformatics

Standards(includingUDI)inCRNs

JamesE.Tcheng,MD,FACC,FSCAIProfessorofMedicine

ProfessorofCommunityandFamilyMedicine(Informatics)james.tcheng@duke.edu

AFewHighlights…Califf – calltosolvethedatasharingproblem…

AFewHighlights…

Platt– an“enormouslift”tounderstandthemeaningofdataatanindividualsite,andtokeepdatacoordinated(inreferencetoSENTINEL)Matheny– translationofdatabetweendatamodelsisnotparticularlydifficult(inreferencetoSENTINEL,PCORNet,i2b2,OHDSI)– problemisCDMimplementationanditscontinuedcoordination

If you don’t know where you are going,

-- YogiBerra(1925-2015)

chances are you will end up somewhere else.

InformaticsandCRNs

• Datadefinition(CDEs,CDMs)• Datacapture(distributedacrossrolesandintegratedintoworkflows)

• Dataquality(fromdocumentmodeltodatamodel- notchartingbyexception)

• UDI(andGUDID,AUDI)

Informatics,CRNsandOpportunities

• Commondatamodels(genericdataaggregation)– SENTINEL,PCORNet,i2b2,OHDSI– Datatransferbetweendatamodels

• Datarepresentation/transferbetweensystems– HL7FHIRportfolio

• Native,interoperablestandardization– Minimumcore(domain-specific)dataelements– UDI:referencedatainGUDID,AUDIdatabases– Commoncoredataelements– Commonadministrative/demographicdataelements

• Structuredreporting

Informatics,CRNsandOpportunities

• Commondatamodels(genericdataaggregation)– SENTINEL,PCORNet,i2b2,OHDSI– Datatransferbetweendatamodels

• Datarepresentation/transferbetweensystems– HL7FHIRportfolio

• Native,interoperablestandardization– Minimumcore(domain-specific)dataelements– UDI:referencedatainGUDID,AUDIdatabases– Commoncoredataelements– Commonadministrative/demographicdataelements

• Structuredreporting

THE Foundational Issue

TowerofBabelPieterBruegeltheElderandPieterBruegeltheYounger,1563

Electronic health information

The Foundational Solution

Registries, CRNs

Procedure reporting systems

Electronic Health Records

Clinical contexts

Native, Interoperable Data Standardization

DataChallenge:MultipleMasters§ Clinicalcare§ Healthsystem§ Payers§ Patients§ Federal,stateprograms§ FDA§ Registries§ Research§ Ohyes…clinicians

Recipients

Producers(akaCustomer#1)

Customer#2:DatabaseDeveloper

§ Databasefieldlabel (i.e.,whatdoyoucallthedataelement,akathe“address”ofthedatainthedatabase)

§ Datatype/format (e.g.,textstring,integer,date,constrainedlist,…)

§ Businessrules (e.g.,rangelimits,consistencychecks,…)

Soyouwanttobuildadatabase…

The Approach

Electronic health information

Registries, CRNsProcedure reporting systems

Electronic Health Records

Clinical contexts

Native, Interoperable Data StandardizationüDevice evaluation (FDA/MDEpiNet) – coronary stents,

peripheral artery revasc, bariatric devices, EP CIEDs, …üAnd their registries – ACC NCDR (CathPVI, ICD), SVS

VQI, ACS MBSAQIP, … à NQRNüMinimum core (domain-specific) CDEs …üCommon CDEs …

SelectingDomain-SpecificConcepts

§ Definetheclinicalstateofthepatient§ Clinicalpresentation,riskfactors

§ Describetechnicalaspects§ Anatomy,proceduredetails

§ Representoutcomesofinterest

“Clean”clinicalconceptssharedacrossclinicalcare,proceduredocumentation,research,and

regulatoryspacesuniquetothedisciplineandneededforanalysis:

ThinkPARSIMONY!

CommonClinicalDataElements

§ Demographics,administrativedata(ONC)§ Vitalsigns,tobaccousehistory(ONC)§ Procedurecodes(CPT)§ Laboratorydata(LOINC)§ Medications(RxNorm)§ UDIandreferencedevicedata(GUDID)

Clinicalconceptssharedacrossclinical,research,andregulatorycontextsNOTuniquetothedisciplineandthatalreadyhavebindings to

standardizedterminologies):

KeyCDEMetadata

HCVstatus:

QuestionorpromptMayhaveassociatedcontrolled

terminology

Value,resultoranswerMayhaveassociatedcontrolled

terminology

1. Clinicalconceptlabel(e.g.,humanpromptforCRF,dataentryscreen)2. Dbfieldlabel(allcaps,nospaces,underscoresonly,limitedchars…)3. Clinicaldefinitionoftheconcept,synonymsthereof4. Datatype/format(e.g.,freetext,constrainedlist,integer,…)5. Allowedvalues(akapermissiblevalues=valueset;VSAC?)6. Allowedvaluesdefinitions7. Businessrules(e.g.,range/editchecks,consistency,validation)8. SDObinding(s)9. Publishedreference(s)

FromConceptstoAction

§ MDEpiNetProjects(BUILD,RAPID,CATNIP,EPPASSION,etc.):identifydomain-specificCDEs§ Clinicalconceptlabel,db label,etc.§ Re-populateGUDID,createAUDI

§ MDEpiNet,NQRN– identifycommonCDEs§ LeverageFHIR§ ImplementacrossqualityregistriesoftheNQRN

§ Informatics– specify/modelthetechnicalrepresentation(CIIC,CIMI,NLM,NCIEVS,others)

Creatingtheecosystem…

Informatics,CRNsandOpportunities

• Native,interoperableCDEstandardization– Processtoidentifycandidateconcepts(domains)– Processtodevelopkeymetadata(clinicians)– Processtoformallymodel(informaticians)– Engagementofsocieties(registryowners)– Engagementofdocumentationsystemowners(commercial)

– EngagementofEHR/EHIowners(commercial)

• UDI…

Informatics,CRNsandOpportunities

• Native,interoperableCDEstandardization…• UDI– andtheintenttouseGUDID(andAUDI)asreferencedatasources– ProcesstoimproveGUDIDdataqualitybydevicecategory

– ProcesstoidentifyclinicallyrelevantconceptsforAUDIbydevicecategory

– Processtodeliver/createAUDI– OtherlessonsoftheLearningUDICommunity

Questions?

Never,everthinkoutsideofthebox!!!

“Dammit, Jim, I’m a Doctor, Not a Computer!”

WhatisStructuredReporting?• Specificdatacapturedbythepersonclosesttothat

data,integratedintoclinicalworkflow(e.g.MA,tech,RN,pt)

• Informaticsformalisms:universal,well-definedcommondataelements;datamodelthatparallels(i.e.,isrepresentationalof)clinicalcaremodel

• Dataiscompiledbythecomputertoproducemostofthecontentinareport;MDvalidatesdata,focusesoncognitiveassessmentandrecommendations

• Output:thestructuredreport• ROI:­ dataquality/quantity, ¯ redundancy/

repetition,timetofinalreports,FTErequirementsàaugmentedknowledge,financialgains

HowIsStructuredReportingDone?• Engineered,best-practiceworkflows• Justintime,contextspecific,highusability,pointofcaredatacaptureviaforms

• Lotsofbusinessrules• OptimizedITformfactors• Computerisacompiler

Inotherwords…• Commandofwhodoeswhatwhen,where,andhow

CommonCDEDefinitionProcess1.DeterminecommondataconceptsacrossMDEpiNetprojects(andtheirregistries)

FromregistryandindustryCRFs2.EnvironmentalscantocatalogeffortsexternaltoMDEpiNet

ONCCommonClinicalDataset,PCPINQRNRegistriesonFHIR(SethBlumenthal),HL7CommonRegistryFramework,CommonDataModels(SENTINEL,PCORNet,OMOP/ODASI),multipleotherefforts

3.Develop“spreadsheet”columnsofdataelementconceptsApplydb developerlens:“WhatdoIneedtobuildthedataelementinadatabase?”e.g.,Longname,db name,datatype,datafieldconstraints,allowed/permissiblevalues,definitions,references

4.Identifyanddevelop/specifycandidatetermsDomainanalysis:crossreferenceofCDEconceptsagainstexistingstandardsFHIRwilllikelyhavespecifiedsomeofthisalreadyatapragmatic,“bestfit”levelONCCommonClinicalDatasetStandardsalsoreferencesexistingstandards

5.Developtechnicalrepresentation,bindtoexistingstandards,andtestNativeinteroperabilitylevel– notjustFHIRtranslationlevelVQIandCathPVI registries– firstdemonstrationsThenACCNCDRandPCPINQRNfamilyofregistries

6.Developasafulltechnicalstandard– logicalmodelingbyCIMI,approvalviaCIICEngageEHR,CVIS,EHIsystemvendorsinhealthcare