How do you represent the complex anatomy of a lesion’s location, such as : “A lesion is in the segment of the popliteal artery above the knee, in the femoral-popliteal major arterial vessel system, of the left leg.”
This example shows how to model complex locations using a combination of location-related TESTs and location variables.
This is probably as complicated for modeling anatomy as it goes, location identification for most abnormality may not require this level of detail, i.e. the aneurysm example.
Approach 1: using result location variables
Row 1:
Shows one or more lesions have been identified in the lower limb region.
Row 2:
Shows the limb that contains lesion is the left leg.
Row 3:
Shows the major vessel that contains a lesion is the left femoro-popliteal peripheral artery.
Row 4:
Shows the lesion is found in the left popliteal artery, in the segment below the knee. Note a TULNKID is created for row 4 ONLY where TULNKID = Lesion 1. This --LNKID is used to connect this lesion to the lesion severity assessment in CV. TULNKID is created in this case as the lesion identifier, it also serves the function to connect the identified lesion to other assessments in different domains.
tu.xpt
tu.xpt
Row
STUDYID
DOMAIN
USUBJID
TUSEQ
TULNKID
TUTEST
TULOC
TUORRES
TUSTRESC
TU Result LOC
TU Result LAT
TU Result LOCDTL
TUMETHOD
TUEVEL
VISITNUM
VISIT
TUDTC
1
TUDY01
TU
40912
1
Lesion Indicator
LOWER LIMB REGION
Y
Y
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
2
TUDY01
TU
40912
2
Limb with Lesion Location Identification
LOWER LIMB REGION
IDENTIFIED
IDENTIFIED
LEG
LEFT
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
3
TUDY01
TU
40912
3
Vessel with Lesion Location Identification
LOWER LIMB REGION
IDENTIFIED
IDENTIFIED
FEMORO-POPLITEAL PERIPHERAL ARTERY
LEFT
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
4
TUDY01
TU
40912
4
Lesion 1
Lesion Location Identification
LOWER LIMB REGION
IDENTIFIED
IDENTIFIED
POPLITEAL ARTERY
LEFT
BELOW THE KNEE
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
Pros:
Reusibility of the result location variables in other domains.
Simplicity: there is only one location for TULOC for the Lesion Location Identification process. Imaging location is treated as the general location for TULOC, and all result locations are under the RESLOC variable.
A combination of location-related tests and location variables help to better support complex anatomical data mapping.
Clarity of data representation
Cons:
there is only one result associated with the location questions.
Vote:
cv.xpt
cv.xpt
Row
STUDYID
DOMAIN
USUBJID
RSSEQ
CVLNKID
CVTEST
CVCAT
CVORRES
VISITNUM
VISIT
RSDTC
1
TUDY01
CV
40912
1
Lesion 1
Lesion Severity
Sponsor-defined Criteria
Severe
2
VISIT 1
2007-02-07
$warningHtml
Approach 2: representing lesion locations as result values
Row 1:
Shows one or more lesions have been identified in the lower limb region.
Row 2:
Shows the limb that contains lesion is the leg.
Row 3:
Shows the leg that contains the lesion is the left one.
Row 4:
Shows the vessel that contains the lesion is the femerol-popliteal peripheral artery.
Row 5:
Shows the femerol-popliteal peripheral artery that contains the lesion is the left one.
Row 6:
Shows the specific lesion is in the popliteal artery.
Row 7:
Shows the popliteal artery that contains the lesion is the left one.
Row 8:
Shows the lesion is in the segment of the left popliteal artery below the knee.
tu.xpt
tu.xpt
Row
STUDYID
DOMAIN
USUBJID
TUSEQ
TUGRPID
TUTEST
TULOC
TUORRES
TUMETHOD
TUEVEL
VISITNUM
VISIT
TUDTC
1
TUDY01
TU
40912
1
Lesion Indicator
Lower limb region
Y
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
2
TUDY01
TU
40912
2
1
Limb with Lesion Location Identification
Lower limb region
Leg
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
3
TUDY01
TU
40912
3
1
Limb with Lesion location Laterality Identification
Leg
Left
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
4
TUDY01
TU
40912
4
2
Vessel with Lesion Location Identification
Lower limb region
Femerol-popliteal peripheral artery
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
5
TUDY01
TU
40912
5
2
Vessel with Lesion Location Laterality Identification
Femerol-popliteal peripheral artery
left
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
6
TUDY01
TU
40912
6
3
Lesion Location Identification
Lower limb region
popliteal artery
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
7
TUDY01
TU
40912
7
3
Lesion Location Laterality Identification
popliteal artery
left
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
8
TUDY01
TU
40912
8
3
Lesion Location Detail Identification
left popliteal artery
below the knee
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
Pros:
lesion location, location laterality and location details are represented as separate TUTESTs - allowing different results
Cons:
The need to create lesion type-specific tests (e.g. aneurysm, calcified annuls, etc), causing an expansion of TUTESTs. For each lesion type, you may create:
xxx location identification
xxx location laterality identification
xxx location directionality identification
xxx location portot identification
xxx location detail identification
Reusibility in other domains is limited, seeing as lesion identification should all be mapped to TU.
Requires good understanding of lesion anatomy and the difference between TSTLOC vs RESLOC in order to map the locations properly and correctly for each corresponding test, step wise.
Just a lot of rows...
Vote:
Approach 3: taking a similar approach as SEND in MI domain modeling where MI test = microscopic examination, and what you find is the result.
I think Diane had proposed this approach before but it didn't go anywhere?