presentation to rcrim san antonio, tx january 15, 2008 meredith nahm, m.s. cv/tb global data...
TRANSCRIPT
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