Shows one or more lesions have been identified in the lower limb region at Visit 1.
Row 2:
Shows lesion 1 is found in the left popliteal artery, below the knee.
Row 3:
Shows lesion 2 is found in the right femoral artery.
Row 4:
Shows one or more lesions have been identified in the lower limb region at Visit 4
Row 5:
Shows after treatment, lesion 1 is not detected, hence RESLOC is not populated, suggesting the treatment had worked.
Row 6:
Shows lesion 2 is still present at the right femoral artery.
Row 7:
Shows there are no more lesions identified in the lower limb region at Visit 8.
Row 8:
Shows after treatments, lesion 1 is not detected, hence RESLOC is not populated, suggesting the treatment had worked.
Row 9:
Shows after treatments, lesion 2 is not detected, hence RESLOC is not populated, suggesting the treatment had worked.
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
Lesion 1
Examination for Abnormality
LOWER LIMB REGION
lesion
(or aneurism, etc)
lesion
POPLITEAL ARTERY
LEFT
BELOW THE KNEE
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
3
TUDY01
TU
40912
3
Lesion 2
Examination for Abnormality
LOWER LIMB REGION
lesion
lesion
FEMORAL ARTERY
RIGHT
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
4
TUDY01
TU
40912
4
Lesion Indicator
LOWER LIMB REGION
Y
Y
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
5
VISIT 4
2007-04-07
5
TUDY01
TU
40912
5
Lesion 1
Examination for Abnormality
LOWER LIMB REGION
lesion not detected
lesion not detected
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
5
VISIT 4
2007-04-07
6
TUDY01
TU
40912
6
Lesion 2
Examination for Abnormality
LOWER LIMB REGION
lesion
lesion
FEMORAL ARTERY
RIGHT
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
5
VISIT 4
2007-04-07
7
TUDY01
TU
40912
7
Lesion Indicator
LOWER LIMB REGION
N
N
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
9
VISIT 8
2007-10-08
8
TUDY01
TU
40912
8
Lesion 1
Examination for Abnormality
LOWER LIMB REGION
lesion not detected
lesion not detected
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
9
VISIT 8
2007-10-08
9
TUDY01
TU
40912
9
Lesion 2
Examination for Abnormality
LOWER LIMB REGION
lesion not detected
lesion not detected
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
9
VISIT 8
2007-10-08
Dataset Debug Message
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Pros:
Reusibility of the result location variables in other domains when needed.
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.
The ability to represent different types of lesions in TUORRES, i.e. aneurysm, calcified annulus or calcified valvular leaflets, stenosis, or an actual cardiovascular lesion (plaque causing stenosis), etc. This approach enables us to avoid creating "lesion-type" specific TUTESTs, such as aneurysm location identification, calcification location identification, etc.
Because we are dealing with a "lesion (TU) domain", the TUTEST= Lesion Indicator, is created as a "general question" that would allow users to create a record on whether or not a lesion is present in a region. As mentioned in bullet point 3, a lesion can be an aneurysm, calcified annulus or valvular leaflets, stenosis and so on - so TUTEST = Lesion Indicator is all encompassing. This TUTEST also allows users to create a negative record when the lesion is no longer detectable after treatments.
This approach aligns the most with what happens in reality (the assessment of an image to find abnormalities).
Cons:
We currently have DIR, LAT, PORTOT, Loc Detail, how many more LOC-related variables might we need if there are more complicated locations info that we need to represent. For example, the graft use-case where we need to indicate a location being a graft, or transplant, we created a NSV for that.