An Early Adopter’s View of Vocabulary for the ICSR

Vocabulary TC and Patient Safety SIG Joint Committee Meeting

May 3, 2004

ICSR Ballot has 70 coded attributes:

Investigation.classCode

Investigation.code

Place.code

ScopingOrganization.code

Organization.code in Investigator choice box

RelatedAEInvestigation.classCode

RelatedAEInvestigation.code

SecondaryCaseNotification.classCode <= OBS

SecondaryCaseNotification.code

PrimarySourceReport.code

PrimarySourceDocument.classCode

PrimarySourceDocument.code

CaseSeriousness.code

CaseSeriousness.value

LiteratureReference.classCode

LiteratureReference.code

Reaction.code

Reaction.value

ReactionRelatedness.code

ReactionRelatedness.value

Severity.code

Severity.value

Outcome.code

Outcome.value

Interpretation.code

Interpretation.value

ConcurrentObservation.code

Intervention.code

Intervention.value

Indication.code

Indication.value

Autopsy.classCode

Autopsy.code

ICSR Ballot has 70 coded attributes:

AutopsyObservation.code

AutopsyObservation.value

ClinicalTrial.code

ProtocolAutorization.code

IdentifierIssuer.code

Medication.code

Procedure.code

Medication.code

AssociatedObservation.code

ProcedureEvent.code

ActionTaken.code

ActionTaken.value

InterventionCharacterization.code

InterventionCharacterization.value

InstalledDevice.code

Device.code

ManufacturerOrReprocessor.code

IdentifierIssuer.code

IdentifiedOrganization.code

DeviceEvaluation.code

EvaluationObservation.code

EvaluationObservation.value

Medication.code

SubstanceAdministrationEvent.code

InterpretationRange.code

AssociatedObservation.code

ActionTaken.code

ActionTaken.value

InterventionCharacterization.code

InterventionCharacterization.value

Procedure.code

SuppliedDrug.code

Medication.code

DistributedProduct.code

Manufacturer.code

MaterialKind.code

EquivalentMedication.code

External Terminologies

• Binding External Code Sets to attributes– Case 1 – Class is a specific observation in LOINC or HL7

• Example: Number of brothers and sisters

– Case 2 – Class is a generic observation• Example: Observation as part of the patient’s clinical statement

to record everything from current weight and age to existing medical conditions (MedDRA, SNOMED-CT, or LOINC)

– Case 3 – EntityCode• Country Code, Drug Code, Ingredient, Blood Product Code,

Device Code, Vaccine?

– Case 4 – Role Code• Occupation and/or Job Code

• Context-Specific Conformance Profiles– Specify allowed bindings in Standard, constrain in Profile

Creating Value Sets from External Code Sets

• Case 1: CE attribute is constrained to one specific external terminology– Blood Product Type, Country Code

• Case 2: CE attribute can be either external terminology A or B– Example: Drug Code (RxNorm or NDC)– Can not mix within a set, class, or report

• Case 3: LOINC concept constrains Observation.code and Answer List in LOINC constrains Observation.value

• Case 4: HL7 concept constrains Observation.code and SNOMED-CT or MedDRA constrains Observation.value– Reaction.code and Reaction.value– ConcurrentObservation.code (can mix LOINC and SNOMED)

• Case 5: CE attribute constrained to one value– Autopsy.code

E2B, MedWatch, VAERS codes

• Add to LOINC or HL7?• May vary by report type (i.e, drug vs. device)

– Represented as Observations (Summaries, judgments)• CaseSeriousness• ReactionRelatedness.code• Severity.code• Outcome.code• Interpretation.code• Intervention.code• Indication.code• ActionTaken.code• InterventionCharacterization.code• DeviceEvaluationObservation.code

– Represented as Acts• Other Report Types• Document Types

– More

Observation Code and Value Datatypes

• Code ST, The plain code symbol defined by the code system. For example, "784.0" is the code symbol of the ICD-9 code "784.0" for headache.

• codeSystem UID, Specifies the code system that defines the code. • codeSystemName ST, The common name of the coding system. • codeSystemVersion ST, If applicable, a version descriptor defined

specifically for the given code system. • displayName ST, A name or title for the code, under which the

sending system shows the code value to its users. • originalText ED, The text or phrase used as the basis for the coding. • Translation SET<CD>, A set of other concept descriptors that

translate this concept descriptor into other code systems.

To LOINC-ize or to HL7-ize?

Observation.code LOINC HL7

code = 12345-6 19423 (under Observtiontype) codeSystem = LOINC OID HL7 ActCode OID

codeSystemVersion = x.x x.x

displayName = DrugCharacterizationCode DrugCharacterizationCode

Observation.valuecode = “S”,”I”, or “C” “S”,”I”, or “C”

codeSystem = LOINC? HL7 ObservationValue OID

codeSystemVersion = x.x x.x

displayName = Suspect, Interacting or Suspect, Interacting or

Concommittant Concommittant