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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

TUSEQTULNKID

TUTEST

TULOC

TUORRES

TUSTRESCTU Result LOCTU Result LATTU Result LOCDTL

TUMETHOD

TUEVEL

VISITNUM

VISIT

TUDTC

1

TUDY01

TU409121
Lesion IndicatorLOWER LIMB REGIONYY


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
2

TUDY01

TU409122
Limb with Lesion Location IdentificationLOWER LIMB REGIONIDENTIFIEDIDENTIFIEDLEGLEFT
CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
3

TUDY01

TU409123
Vessel with Lesion Location IdentificationLOWER LIMB REGIONIDENTIFIEDIDENTIFIEDFEMORO-POPLITEAL PERIPHERAL ARTERYLEFT
CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
4

TUDY01

TU409124Lesion 1Lesion Location IdentificationLOWER LIMB REGIONIDENTIFIEDIDENTIFIEDPOPLITEAL ARTERYLEFTBELOW THE KNEECT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Pros:
  1. Reusibility of the result location variables in other domains.
  2. 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.
  3. A combination of location-related tests and location variables help to better support complex anatomical data mapping.
  4. Clarity of data representation
Cons:
  1. there is only one result associated with the location questions.

cv.xpt

cv.xpt

Row

STUDYID

DOMAIN

USUBJID

RSSEQCVLNKID

CVTEST

CVCAT

CVORRES

VISITNUM

VISIT

RSDTC

1

TUDY01

CV409121Lesion 1Lesion SeveritySponsor-defined CriteriaSevere2VISIT 12007-02-07
$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

TUSEQTUGRPID

TUTEST

TULOC

TUORRES

TUMETHOD

TUEVEL

VISITNUM

VISIT

TUDTC

1

TUDY01

TU409121
Lesion IndicatorLower limb regionYCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
2

TUDY01

TU4091221Limb with Lesion Location IdentificationLower limb regionLegCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
3

TUDY01

TU4091231Limb with Lesion location Laterality IdentificationLegLeftCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
4

TUDY01

TU4091242Vessel with Lesion Location IdentificationLower limb region

Femerol-popliteal peripheral artery

CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
5

TUDY01

TU4091252Vessel with Lesion Location Laterality IdentificationFemerol-popliteal peripheral arteryleftCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
6

TUDY01

TU4091263Lesion Location IdentificationLower limb regionpopliteal arteryCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
7

TUDY01

TU4091273Lesion Location Laterality Identificationpopliteal arteryleftCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
8

TUDY01

TU4091283Lesion Location Detail Identificationleft popliteal arterybelow the kneeCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Pros:
  1. lesion location, location laterality and location details are represented as separate TUTESTs - allowing different results
Cons:
  1. The need to create lesion type-specific tests (aneurysm, calcified annuls, etc), causing an expansion of TUTESTs.
  2. Reusibility in other domains is limited, seeing as lesion identification should all be mapped to TU.
  3. Requires good understanding of lesion anatomy and the difference between TSTLOC vs RESLOC in order to map the locations properly and correctly for each test, step wise.
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