Presentation to RCRIMSan Antonio, TXJanuary 15, 2008

Meredith Nahm, M.S.CV/TB Global Data Standards Efforts

Therapeutic Area Data Standards: Cardiovascular &Tuberculosis Clinical

Content Standards

Supported by BAA-RM-04-23

Purpose:

Patient

Clinician

Healthcare Data Systems

Patient care

Quality Improvement

Research

Reimbursement

Post Marketing Safety

Decision Support

Administration & Mgt.

Public Health Reporting

…

Data Uses

Single Source Multiple Uses

Goals

• Focus on methodology for developing therapeutic area data standards

• Produce useful products for CV/TB• Report experience, process, best

practices

Project Goal StatusCreate stakeholder group Complete

Create master data element list from healthcare and related secondary uses

Complete

Define a set of data elements according to the ISO 11179 standard (CV 21-TB 90 data elements)

Complete

Develop consensus clinical definitions for the data elements Complete

Create a dynamic model of the domain represented through an activity diagram, using the UML standard

Complete

Create a research representation of the data elements in the CDISC SDTM model. *CV will create representation in the future

Complete*

Make the resulting standards available to the public through an ANSI accredited balloting process

In progress, 2008

Methods

• Standardize at source healthcare– Data element as unit of exchange– Specificity sufficient for semantic interoperability– Work within HL7

• Include all Stakeholders– Research representation CDISC– Public Health Representation CDC– Quality Imp. Professional Societies

Results

Section 1: Use cases and storyboards (H)

Section 2: Data elements and clinical definitions (U)

Section 3: Domain Class model (H)

Section 4: Domain Activity diagram (H)

Section 5: Data collection forms (R)

Section 6: Suggestions for SDTM representation (R)

H = Healthcare / R = Research / U = Universal H = Healthcare / R = Research / U = Universal

class Diagnosis

Common::RegistrationAsPatient

+ evaluationReasonCode: char+ uniquePatientId: char

Specimen

+ bodySiteCode: char+ collectionDate: Date+ specimenTypeCode: char

TuberculosisDiagnosis

+ confirmationMethodCode: char+ diagnosisticConclusion: char+ effectiveDate: Date

BodySiteAffected

+ anatomicSiteCode: char+ primaryIndicator: boolean

Organism

+ genotypeCode: char+ mycobacteriumSpeciesCode: char

SocialHistory

+ dateOfRecording: Date+ riskFactorForTuberculosisExposure: char

ContactRelationship

+ contactTypeCode: char

SignsAndSymptoms

+ dateOfRecording: Date+ durationOfCough: int+ durationOfFever: int+ presenceOfCough: boolean+ underlyingPulmonaryDisease: char

BCGVaccination

+ mostRecentVaccinationDate: Date+ multipleVaccinationIndicator: boolean+ reportingMethodCode: char+ vaccinationTimingCode: char

Imaging::Image

+ imageDate: Date+ imageTypeCode: char+ imagingTimePointCode: char+ interpretationCode: char+ reportText: char

Susceptibility

+ challengedSubstanceCode: char+ compoundConcentration: int+ resultCode: char

TuberculinSkinTest

+ blisteringStatus: char+ interpretationCode: char+ mantouxStrengtn: int+ quantitativeResult: int

Common::Prov iderOrganization

+ name: char

Common::Person

+ dateOfBirth: Date+ dateOfDeath: Date+ deathIndicator: boolean+ emailAddress: char+ genderCode: char+ name: char+ postalAddress: char+ socialInsuranceNumber: char+ telephoneNumber: char

Common::PatientEncounter

+ chiefComplaint: char+ dischargeDate: int+ inpatientStatsIndicator: boolean+ startDate: Date

Common::Clinician

+ emailAddress: char+ name: char+ postalAddress: char+ professionalQualificationCode: char+ telephoneNumber: char

Treatment

+ AdministrationEvent

+ AdministrationRecorder

+ Assessment

+ CourseOfTreatment

+ DrugOrder

+ TreatmentInitiation

+ TreatmentInterruption

+ TreatmentTermination

+

(from TB_DAM)

HIVTesting

+ cd4AbsoluteCount: int+ cd4Percent: int+ specimenTypeCode: char+ testingDate: Date+ testTypeCode: char

SmearTest

+ InterpretationCode: char+ quantitativeResultCode: char+ SpecimenProcessingForSmearCode: char

InteferonGammaAssay

+ assayResultInterpretationCode: char+ elisaResult: int+ elispotResult: int

SolidMediaCulture

+ cultureMediaType: char+ resultCode: char

LiquidMediaCulture

+ cultureMediaType: char+ resultCode: char

Test

+ effectiveDateTime: int+ testingStatusCode: char+ typeCode: char

NucleicAcidAmplification

+ InterpretationCode: char

Imaging

+ Image

+ ImageEvolution

+ ImagingDetail

(from TB_DAM)

StatusSummaryInformation

+ bacillusCalmetteGuerinStatusCode: char+ chestRadiographStatusCode: char+ computerAssistedTomographyIndicator: boolean+ episodeTypeCode: char+ hivStatusIndicator: boolean+ hivStatusMethodCode: char+ hivTestingIndicator: boolean+ magneticResonanceImagingIndicator: boolean+ patientTuberculosisStatusCode: char+ predisposingMedicalHistoryIndicator: boolean+ statusEffectiveDate: Date+ studyEnrollmentIndicator: boolean+ susceptibil ityTestingIndicator: boolean+ treatmentInterrruptionIndicator: boolean+ treatmentStatusCode: char+ tuberculosisTreatmentPhaseCode: char+ ultrasoundIndicator: boolean+ vaccineStatusCode: char

Name: DiagnosisAuthor: Mead WalkerVersion: 1.0Created: 7/1/2001 12:00:00 AMUpdated: 10/22/2007 2:59:44 PM

TuberculosisSymptom

+ dateOfOnsetOfTuberculosisSymptom: date- tuberculosisSymptomCode: char

MedicalHistory

+ predisposingMedicalHistory: char

+person

1

+signsAndSymptoms

0..1

+tuburculosisDiagnosis 1

+bodySiteAffectedCollection 0..*

+person

1+specimenCollection 0..*

+clinician

1+tuberculosisDiagnosisCollection

0..*

+sourcePerson1

+contactRelationshipCollection

0..*

+registrationAsPatient 1

+encounterCollection 0..*

+providerOrganization 1

+registrationAsPatientCollection

0..*

+person 1

+registrationAsPatientCollection 0..*

+organism

1

+susceptibil ityCollection 0..*

+Person

1

+riskFactorCollection

0..*

+liquidMediaCulture 0..1

+organismCollection 0..*

+targetPerson0..1

+contactRelationshipCollection

0..*

+clinician1

+patientEncounterCollection 0..*

+SignsAndSymptoms

1

+MedicalHistoryCollection 0..*+signsAndSymptoms 1

+TuberculosisSymptomCollection 0..*

+specimen 0..1

+testCollection 0..*

+clnician

1

+riskFactorCollection 0..*

+person 1

+tuberculosisDiagnosisCollection

0..*

+person

1

+bcgVaccinationCollection

0..*

+testCollection0..*

+person

1

+patientEncounter

0..1

+testCollection

0..*+clinician

1

+hivTestingCollection

0..*

+person 1

+hivTestingCollection

+Person

1

+StatusSummaryInformation

0..1

+person 1

+imageCollection

0..*

+clinician

1

+testCollection

0..*

+orderingClinician 1

+ImageCollection 0..*

+InterpretingClinician 1

+ImageCollection

+clinician1

+signsAndSymptoms 0..1

+solidMediaCulture 0..1

+organismCollection 0..*

+clinician1

+bcgVaccinationCollection 0..*

TB Class Model

class Diagnosis

Common::RegistrationAsPatient

+ evaluationReasonCode: char+ uniquePatientId: char

Specimen

+ bodySiteCode: char+ collectionDate: Date+ specimenTypeCode: char

TuberculosisDiagnosis

+ confirmationMethodCode: char+ diagnosisticConclusion: char+ effectiveDate: Date

BodySiteAffected

+ anatomicSiteCode: char+ primaryIndicator: boolean

Organism

+ genotypeCode: char+ mycobacteriumSpeciesCode: char

SocialHistory

+ dateOfRecording: Date+ riskFactorForTuberculosisExposure: char

ContactRelationship

+ contactTypeCode: char

SignsAndSymptoms

+ dateOfRecording: Date+ durationOfCough: int+ durationOfFever: int+ presenceOfCough: boolean+ underlyingPulmonaryDisease: char

BCGVaccination

+ mostRecentVaccinationDate: Date+ multipleVaccinationIndicator: boolean+ reportingMethodCode: char+ vaccinationTimingCode: char

Imaging::Image

+ imageDate: Date+ imageTypeCode: char+ imagingTimePointCode: char+ interpretationCode: char+ reportText: char

Susceptibility

+ challengedSubstanceCode: char+ compoundConcentration: int+ resultCode: char

TuberculinSkinTest

+ blisteringStatus: char+ interpretationCode: char+ mantouxStrengtn: int+ quantitativeResult: int

Common::Prov iderOrganization

+ name: char

Common::Person

+ dateOfBirth: Date+ dateOfDeath: Date+ deathIndicator: boolean+ emailAddress: char+ genderCode: char+ name: char+ postalAddress: char+ socialInsuranceNumber: char+ telephoneNumber: char

Common::PatientEncounter

+ chiefComplaint: char+ dischargeDate: int+ inpatientStatsIndicator: boolean+ startDate: Date

Common::Clinician

+ emailAddress: char+ name: char+ postalAddress: char+ professionalQualificationCode: char+ telephoneNumber: char

Treatment

+ AdministrationEvent

+ AdministrationRecorder

+ Assessment

+ CourseOfTreatment

+ DrugOrder

+ TreatmentInitiation

+ TreatmentInterruption

+ TreatmentTermination

+

(from TB_DAM)

HIVTesting

+ cd4AbsoluteCount: int+ cd4Percent: int+ specimenTypeCode: char+ testingDate: Date+ testTypeCode: char

SmearTest

+ InterpretationCode: char+ quantitativeResultCode: char+ SpecimenProcessingForSmearCode: char

InteferonGammaAssay

+ assayResultInterpretationCode: char+ elisaResult: int+ elispotResult: int

SolidMediaCulture

+ cultureMediaType: char+ resultCode: char

LiquidMediaCulture

+ cultureMediaType: char+ resultCode: char

Test

+ effectiveDateTime: int+ testingStatusCode: char+ typeCode: char

NucleicAcidAmplification

+ InterpretationCode: char

Imaging

+ Image

+ ImageEvolution

+ ImagingDetail

(from TB_DAM)

StatusSummaryInformation

+ bacillusCalmetteGuerinStatusCode: char+ chestRadiographStatusCode: char+ computerAssistedTomographyIndicator: boolean+ episodeTypeCode: char+ hivStatusIndicator: boolean+ hivStatusMethodCode: char+ hivTestingIndicator: boolean+ magneticResonanceImagingIndicator: boolean+ patientTuberculosisStatusCode: char+ predisposingMedicalHistoryIndicator: boolean+ statusEffectiveDate: Date+ studyEnrollmentIndicator: boolean+ susceptibil ityTestingIndicator: boolean+ treatmentInterrruptionIndicator: boolean+ treatmentStatusCode: char+ tuberculosisTreatmentPhaseCode: char+ ultrasoundIndicator: boolean+ vaccineStatusCode: char

Name: DiagnosisAuthor: Mead WalkerVersion: 1.0Created: 7/1/2001 12:00:00 AMUpdated: 10/22/2007 2:59:44 PM

TuberculosisSymptom

+ dateOfOnsetOfTuberculosisSymptom: date- tuberculosisSymptomCode: char

MedicalHistory

+ predisposingMedicalHistory: char

+person

1

+signsAndSymptoms

0..1

+tuburculosisDiagnosis 1

+bodySiteAffectedCollection 0..*

+person

1+specimenCollection 0..*

+clinician

1+tuberculosisDiagnosisCollection

0..*

+sourcePerson1

+contactRelationshipCollection

0..*

+registrationAsPatient 1

+encounterCollection 0..*

+providerOrganization 1

+registrationAsPatientCollection

0..*

+person 1

+registrationAsPatientCollection 0..*

+organism

1

+susceptibil ityCollection 0..*

+Person

1

+riskFactorCollection

0..*

+liquidMediaCulture 0..1

+organismCollection 0..*

+targetPerson0..1

+contactRelationshipCollection

0..*

+clinician1

+patientEncounterCollection 0..*

+SignsAndSymptoms

1

+MedicalHistoryCollection 0..*+signsAndSymptoms 1

+TuberculosisSymptomCollection 0..*

+specimen 0..1

+testCollection 0..*

+clnician

1

+riskFactorCollection 0..*

+person 1

+tuberculosisDiagnosisCollection

0..*

+person

1

+bcgVaccinationCollection

0..*

+testCollection0..*

+person

1

+patientEncounter

0..1

+testCollection

0..*+clinician

1

+hivTestingCollection

0..*

+person 1

+hivTestingCollection

+Person

1

+StatusSummaryInformation

0..1

+person 1

+imageCollection

0..*

+clinician

1

+testCollection

0..*

+orderingClinician 1

+ImageCollection 0..*

+InterpretingClinician 1

+ImageCollection

+clinician1

+signsAndSymptoms 0..1

+solidMediaCulture 0..1

+organismCollection 0..*

+clinician1

+bcgVaccinationCollection 0..*

TB ActivityModel

act TB Diagnosis

Interv iew & HistoryClinical Presentation

Administer PPD SkinTest

Perform IGRA Testing Perform Chest Xray

Collect Sputum culture

Culture SpecimenPerform AFB Smear

Microbiology Testing

Perform NAA Rapid Test

Recommend AlteredPrescription

Report Confirmed Case

Eligible for Prophylaxis?(within applicable region)

Prov ide Medication for TBProphylaxis

Evaluate AvailableResults

Evaluate Test Results

Stop Treatment

Determine HIV Status

No Further Action Notifiable Condition

Report

Suscepibility Testing

No Action Necessary

Treatment

Positive Result?

Suspect TB ?

Rule Out TB

Latent TB

positive culture

Susceptible to Standard RX?

[NO (third test)]

[NO (first or second test)]

[If capable of test]

[Positive PPD, negativeother results]

[If capable of test]

[NO]

[If possible][If possible][If possible]

[If capable of test]

[If testing not feasible, Ifpresentation conclusive]

[Testing and clinical presentationindicate presence of TB]

[Yes]

[Negative result]

[Positive Result]

[YES]

[If able to perform at least one confirmatory test]

[If further testing not feasible, Ifclear presence of TB]

[Treatment needed]

[NO]

[If treatment not already started]

[YES][Treatment Not Indicated]

act TB Diagnosis

Interv iew & HistoryClinical Presentation

Administer PPD SkinTest

Perform IGRA Testing Perform Chest Xray

Eligible for Prophylaxis?(within applicable region)

Ev aluate Av ailableResults

Determine HIV Status

No Further Action Notifiable Condition

Report

No Action Necessary

Treatment

Positive Result?

Suspect TB ?

Rule Out TB

Latent TB

positive culture

Susceptible to Standard RX?

[NO (third test)]

[NO (first or second test)]

[If capable of test]

[Positive PPD, negativeother results]

[If capable of test]

[NO]

[If possible][If possible][If possible]

[If capable of test]

[If testing not feasible, Ifpresentation conclusive]

[Testing and clinical presentationindicate presence of TB]

[Yes]

[Negative result]

[Positive Result]

[YES]

[If able to perform at least one confirmatory test]

[If further testing not feasible, Ifclear presence of TB]

[Treatment needed]

[NO]

[If treatment not already started]

[YES][Treatment Not Indicated]

Proposal for Clinical Content Work

• Clinical Context Experts:Clinicians / Clinical Professional Societies

• HL7 Clinical Interoperability Council (CIC) as forum

• Define Data Elements for clinical areas

• Construct DAMs

• CIC as forum for mentoring, knowledge sharing and maintaining consistency

• DAMs available to TCs and SIGs for work product / template specification

• Identify methods for including RCRIM knowledge

Next Steps:

Public Review Release - Research

HL7 Review – Healthcare

Industry & Focus Group Webinars

Discussion

• Materials should be available for HL7 public Review

• Ballot Process

Questions ?Thank you !