Study Conduct Sub-Domain::PerformedMedicalConditionResult

: Public Class

Created:	7/26/2007 12:05:41 PM
Modified:	4/9/2019 5:52:25 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{8E165368-DDE3-42db-A793-40350AC7B913}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View AE: Adverse Event, View SC: Study Conduct, SDTM IG v3.1.3, SDTM IG v3.2, Common Data Model Harmonization (CDMH), Diagnosis, National Marrow Donor Program (NMDP)

DEFINITION: Any sign, symptom, disease, or other medical occurrence. EXAMPLE(S): death, back pain, headache, pulmonary embolism, heart attack, pregnancy, flu, broken bone, menstrual period, depression OTHER NAME(S): Clinical Events Medical History NOTE(S): This condition may have been recalled by the subject or a caregiver or provided in their medical record.

Attributes
Associations From
Tagged Values
Other Links

Attribute

Public IVL<TS.DATETIME>
occurrenceDateRange

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CDASHv1.1=MH.MHENDAT
Map:CDASHv1.1=MH.MHSTDAT
Map:CDMHv1.0=PerformedMedicalConditionResult.occurrenceDateRange
Map:CTRv1.0=PerformedMedicalConditionResult.occurrenceDateRange
Map:HCTv1.0=CDE 2871898:Occurrences.Date fungal infection occurred
Map:HCTv1.0=CDE 2787854:Adverse Events.Date engraftment syndrome occurred:
Map:HCTv1.0=CDE 2960491:Adverse Events.Date of graft failure:
Map:LSDAMv2.2.3Plus=PerformedMedicalHistoryResult.occurrenceDateRange
Map:NCI CRF Standard=CDE 2736881v1.0: Personal Medical History Ongoing Indicator
Map:OMOPv5.2=CONDITION_OCCURRENCE.condition_start_date
Map:OMOPv5.2=CONDITION_OCCURRENCE.condition_start_datetime
Map:OMOPv5.2=CONDITION_OCCURRENCE.condition_end_datetime
Map:OMOPv5.2=CONDITION_OCCURRENCE.condition_end_date
Map:PCORNetv3.1=Condition.onset_date
Map:PCORNetv3.1=Condition.resolve_date
Map:PCORNetv4.0=Condition.onset_date
Map:PCORNetv4.0=Condition.resolve_date
Map:SDTM IGv3.1.1=MH.MHSTDTC
Map:SDTM IGv3.1.1=MH.MHENDTC
Map:SDTM IGv3.1.2=CE.CESTDTC
Map:SDTM IGv3.1.2=MH.MHENDTC
Map:SDTM IGv3.1.2=CE.CEENDTC
Map:SDTM IGv3.1.2=MH.MHSTDTC
Map:SDTM IGv3.1.2=MH.MHENRTPT
Map:SDTM IGv3.1.2=MH.MHENRF
Map:SDTM IGv3.2=CE.CEENDTC
Map:SDTM IGv3.2=CE.CESTDTC
Map:SDTM IGv3.2=MH.MHSTDTC
Map:SDTM IGv3.2=MH.MHENDTC

Notes:

DEFINITION: The date and time span in which the medical condition began and ended. EXAMPLE(S): OTHER NAME(S): Onset date, resolution date, duration. NOTE(S): These may be partial dates or durations (duration is the width property of the IVL#lt;TS#gt; datatype). A condition may be considered to have ended when a subject returns to their baseline state.

Public CD
occurrenceDateRangeValidationCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:HCTv1.0=CDE 2795658:Lab Results.If necessary, please validate the neutrophil recovery date response.

Notes:

DEFINITION: A coded value specifying the degree of authoritativeness or certitude of the occurrence date. EXAMPLE(S): "date estimated" "date #gt; 100 days, date is correct" "date #lt; 100 days, date is correct" OTHER NAME(S): NOTE(S): The concept of "date unknown" is captured by a nullFlavor of "UNK" on the dateRange attribute, rather than a code in this attribute. A patient might have recovered from neutrophil in the past, but isn't sure of the exact date and state "I think it was in January of 2005". This would be recorded with an occuranceDateRange of "January 2005" and an uncertainOccuranceDateCode of "estimated".

Public IVL<INT>
occurrenceStudyDayRange

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:SDTM IGv3.1.3=MH.MHDY

Notes:

DEFINITION: The relative timing for a medical condition expressed as the number of days offset from the study-defined reference activity (e.g., date of registration, start of treatment) for this particular experimental unit. EXAMPLE(S): Day 1, Days 10-20 OTHER NAME(S): Study Day NOTE(S): Derived from the occurrenceDateRange of this medical condition result minus the dateRange of the reference activity + 1. The study-defined reference activity can be different from study to study. The study day for a date after this reference activity is a positive integer calculated as the difference in the two dates + 1. The study day for dates before the reference activity is a negative integer calculated as the difference between the two dates. Note that this means there is no "Day 0."

Public CD
endRelativeToReferenceCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRv1.0=PerformedMedicalConditionResult.endRelativeToReferenceCode
Map:LSDAMv2.2.3Plus=PerformedMedicalHistoryResult.endRelativeToReferenceCode
Map:SDTM IGv3.1.1=MH.MHENRF

Notes:

DEFINITION: A coded value specifying the end of the medical condition event with respect to the sponsor-defined reference period. EXAMPLE(S): before, during, during/after, after OTHER NAME(S): NOTE(S): Derived from comparing PerformedSubstanceAdministration.dateRange(IVL#lt;TS.DATETIME#gt;).high and PerformedStudySubjectMilestone.studyReferenceDateRange. Sponsors should define the reference period in the study metadata. This may be populated when a start date is not collected.

Public CD
severityCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:HCTv1.0=CDE 3021198:Diagnosis.Specify the severity of the valvular insufficiency:

Notes:

DEFINITION: A coded value specifying the intensity of the condition. EXAMPLE(S): Moderate could be used to describe acne. Values of: none,mild or trivial,moderate or severe,valve replacement,unknown could be used for a aorta valvular insufficiency OTHER NAME(S): NOTE(S): Derived from PerformedClinicalInterpretation.value(ANY=#gt;CD) WHERE PerformedClinicalInterpretation #gt; PerformedObservation [severity assessment] #gt; DefinedObservation.nameCode = "assess severity" AND PerformedObservation [severity assessment] #gt; AssessedResultRelationship #gt; PerformedMedicalConditionResult

Public BL
clinicallySignificantIndicator

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	True
IsID:	False

Map:HCTv1.0=CDE 2759600:Diagnosis.Was there a coexisting significant hemorrhage?

Notes:

DEFINITION: Specifies whether a subject's clinical condition is important based on judgment. EXAMPLE(S): OTHER NAME(S): NOTE(S): Derived from PerformedClinicalInterpretation.value(ANY=#gt; BL) WHERE PerformedClinicalInterpretation #gt; PerformedObservation #gt; DefinedObservation.nameCode = "assess clinical significance".

Public BL
medicalHistoryIndicator

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	True
IsID:	False

Map:CTRv1.0=PerformedMedicalConditionResult.medicalHistoryIndicator
Map:SDTM IGv3.1.2=MH.DOMAIN

Notes:

DEFINITION: Specifies whether the condition is considered part of the historical record of a subject, that is, it did not occur within the bounds of the study. EXAMPLE(S): OTHER NAME(S): NOTE(S): Derived from the medical history indicator on the activity (PerformedActivity.medicalHistoryIndicator) which produced this result.

Public CD
conditionStatusCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CDMHv1.0=PerformedMedicalConditionResult.conditionStatusCode
Map:OMOPv5.2=CONDITION_OCCURRENCE.condition_status_concept_id
Map:PCORNetv3.1=Condition.condition_status
Map:PCORNetv4.0=Condition.condition_status

Notes:

DEFINITION: A coded value specifying the state of the condition. EXAMPLE(S): AC = Active RS = Resolved IN = Inactive NI = No information UN = Unknown OT = Other OTHER NAME(S): NOTE(S):

Public ST
conditionStatusChangeReason

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CDMHv1.0=PerformedMedicalConditionResult.conditionStatusChangeReason
Map:OMOPv5.2=CONDITION_OCCURRENCE.stop_reason

Notes:

DEFINITION: The text and/or code that describes why a condition was no longer present. EXAMPLE(S): Discharged Resolved OTHER NAME(S): Condition Occurrence Stop Reason NOTE(S): Note that a value in this attribute does not necessarily imply that the condition is no longer occurring.

Element	Source Role	Target Role
PerformedSubstanceAdministration Class	Name: addressingPerformedSubstanceAdministration	Name: addressedPerformedMedicalConditionResult
Details: DESCRIPTION:<br/>Each PerformedSubstanceAdministration might address one or more PerformedMedicalConditionResult. Each PerformedMedicalConditionResult might be addressed by one or more PerformedSubstanceAdministration.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:caAERSv2.2	StudyParticipantPreExistingCondition
Details:
Map:CDMHv1.0	PerformedMedicalConditionResult
Details:
Map:CTRv1.0	PerformedMedicalConditionResult
Details:
Map:NCI CRF Standard	MedicalHistory
Details:
Map:OMOPv5.2	CONDITION_OCCURRENCE
Details:
Map:PCORNetv3.1	Condition
Details:
Map:PCORNetv4.0	Condition
Details:
Map:SDTM IGv3.1.3	CE
Details:
Map:SDTM IGv3.2	CE
Details:

Object	Type	Connection	Direction	Notes
PerformedObservationResult	Class	Generalization	To	DESCRIPTION: Each PerformedMedicalConditionResult always specializes one PerformedObservationResult. Each PerformedObservationResult might be specialized by one PerformedMedicalConditionResult. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):