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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

TU Result LOCTU Result LATTU Result LOCDTL

TUMETHOD

TUEVEL

VISITNUM

VISIT

TUDTC


TURLGFFL
1

TUDY01

TU409121
Lesion IndicatorLOWER LIMB REGIONY


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07

2

TUDY01

TU409122Lesion 1Lesion Location IdentificationLOWER LIMB REGIONIDENTIFIEDPOPLITEAL ARTERYLEFTABOVE KNEECT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07

3

TUDY01

TU409123Graft Lesion 1Lesion Location IdentificationLOWER LIMB REGIONIDENTIFIEDLEFT FEMORO-POPLITEALLEFTPROXIMAL ANASTOMOSIS,  5MM FROM THE ORIGIN OF THE GRAFTCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
Y

Dataset Debug Messages

  • There is a leading, trailing, or non-breaking space in the dataset.
  • Please remove all formatting (see How to Clear Formatting).

TU NSV Metadata

VariableLabelTypeRoleOrigin
TURLGFFLResult location is Graft FlagtextNon-Standard Record QualifierCRF

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. Clarity of data representation
Cons:
  1. "Identified" is a pre-specified result, this just seems wrong.
  2. We currently have DIR, LAT, PORTOT, Loc Detail, how many more LOC-related variables might we need if there are more locations info that we need to represent. For example, the graft use-case where we need to indicate that a location is a graft, or transplant, we created a NSV for that.
Vote:

NO

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 lesion is in the POPLITEAL ARTERY.
Row 3:Shows the lesion is in the left POPLITEAL ARTERY.
Row 4:Shows the lesion is in the left POPLITEAL ARTERY, in the segment above the knee.
Row 5:Shows the lesion is in the LEFT FEMORO-POPLITEAL GRAFT.
Row 6:Shows the lesion is in the LEFT FEMORO-POPLITEAL GRAFT, PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT.

tu.xpt

tu.xpt

Row

STUDYID

DOMAIN

USUBJID

TUSEQTULNKID

TUTEST

TULOC

TULAT

TUORRES

TUMETHOD

TUEVEL

VISITNUM

VISIT

TUDTC

1

TUDY01

TU409121
Lesion IndicatorLOWER LIMB REGION
YCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
2

TUDY01

TU409122Lesion 1Lesion Location IdentificationLOWER LIMB REGION
POPLITEAL ARTERYCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
3

TUDY01

TU409123Lesion 1Lesion Location Laterality IdentificationPOPLITEAL ARTERY
LEFTCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
4

TUDY01

TU409124Lesion 1Lesion Location Detail IdentificationPOPLITEAL ARTERYLEFTABOVE KNEECT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
5

TUDY01

TU409121Graft Lesion 1Lesion Location IdentificationLOWER LIMB REGION
LEFT FEMORO-POPLITEAL GRAFTCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
6

TUDY01

TU409122Graft Lesion 1Lesion Location Detail IdentificationLEFT FEMORO-POPLITEAL GRAFT
PROXIMAL ANASTOMOSIS,  5MM FROM THE ORIGIN OF THE GRAFTCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07

Dataset Debug Messages

  • There are two leading, trailing, or non-breaking spaces in the dataset.
  • Please remove all formatting (see How to Clear Formatting).

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.
  2. Represent Graft as part of the ORRES, instead of using a NSV.
Cons:
  1. 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:
    1. xxx location identification
    2. xxx location laterality identification
    3. xxx location directionality identification
    4. xxx location portot identification
    5. xxx location detail identification
  2. Reusibility in other domains is limited, seeing as lesion identification should all be mapped to TU.
  3. In this set up, the previous result becomes the location for the next TEST, this 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.
Vote:

NO

Approach 3: taking a similar approach as SEND in MI domain modeling where MI test = microscopic examination, the identified abnormality is the result and the location of the said abnormality is mapped to RESLOC.


Row 1:Shows one or more lesions have been identified in the lower limb region.
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.
Row 5:Shows after treatments, lesion 1 is unidentifiable, suggesting the treatments 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.
Row 8:Shows after treatments, lesion 1 is unidentifiable, suggesting the study treatment had worked.
Row 9:Shows after treatments, lesion 2 is unidentifiable, suggesting the study treatment had worked.

tu.xpt

tu.xpt

Row

STUDYID

DOMAIN

USUBJID

TUSEQ

TULNKID

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

TU409122Lesion 1Examination for AbnormalityLOWER LIMB REGIONlesionlesionPOPLITEAL ARTERYLEFTBELOW THE KNEECT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
3

TUDY01

TU409123Lesion 2Examination for AbnormalityLOWER LIMB REGIONlesionlesionFEMORAL ARTERYRIGHT
CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
4

TUDY01

TU409124
Lesion IndicatorLOWER LIMB REGIONYY


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR5VISIT 42007-04-07
5

TUDY01

TU409125Lesion 1Examination for AbnormalityLOWER LIMB REGIONLesion UnidentifiableLesion Unidentifiable


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR5VISIT 42007-04-07
6

TUDY01

TU409126Lesion 2Examination for AbnormalityLOWER LIMB REGIONlesionlesionFEMORAL ARTERYRIGHT
CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR5VISIT 42007-04-07
7

TUDY01

TU409127
Lesion IndicatorLOWER LIMB REGIONNN


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR9VISIT 82007-10-08
8

TUDY01

TU409128Lesion 1Examination for AbnormalityLOWER LIMB REGIONLesion UnidentifiableLesion Unidentifiable


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR9VISIT 82007-10-08
9

TUDY01

TU409129Lesion 2Examination for AbnormalityLOWER LIMB REGIONLesion UnidentifiableLesion Unidentifiable


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR9VISIT 82007-10-08
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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. We can represent the different types of lesions in TUORRES, i.e. aneurysm, calcified- annulus or -valvular leaflets, stenosis, or an actual lesion in TUORRES, thusly avoiding the creation of lesion-type specific TUTESTs.
  4. 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 2, a lesion can be an aneurysm, calcified annulus or valvular leaflets, stenosis and so on - so TUTEST = Lesion Indicator is all encompassing. This question also allows users to create a negative record when the lesion is no longer identifiable after treatments.
  5. We all like this better (smile) yay win~
Cons:
  1. We currently have DIR, LAT, PORTOT, Loc Detail, how many more LOC-related variables might we need if there are more locations info that we need to represent. For example, the graft use-case where we need to indicate that a location is a graft, or transplant, we created a NSV for that.
Vote:

YES

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