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Row 1: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.

any body system domain.xpt

body-system domain.xpt

Row

STUDYID

DOMAIN

USUBJID

SEQ

LNKID

TEST

LOC

ORRES

STRESCResult LOCResult LATResult LOCDTL

METHOD

EVEL

VISITNUM

VISIT

TUDTC

1

TUDY01

any body system domain409121
Abnormality IndicatorLOWER LIMB REGIONYY


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
2

TUDY01

any body system domain409122Lesion 1Examination for AbnormalityLOWER LIMB REGION

lesion

(or aneurism, etc)

lesionPOPLITEAL ARTERYLEFTBELOW THE KNEECT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
3

TUDY01

any body system domain409123Lesion 2Examination for AbnormalityLOWER LIMB REGIONlesionlesionFEMORAL ARTERYRIGHT
CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
4

TUDY01

any body system domain409124
Abnormality IndicatorLOWER LIMB REGIONYY


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR5VISIT 42007-04-07
5

TUDY01

any body system domain409125Lesion 1Examination for AbnormalityLOWER LIMB REGIONlesion not detectedlesion not detected


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR5VISIT 42007-04-07
6

TUDY01

any body system domain409126Lesion 2Examination for AbnormalityLOWER LIMB REGIONlesionlesionFEMORAL ARTERYRIGHT
CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR5VISIT 42007-04-07
7

TUDY01

any body system domain409127
Abnormality IndicatorLOWER LIMB REGIONNN


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR9VISIT 82007-10-08
8

TUDY01

any body system domain409128Lesion 1Examination for AbnormalityLOWER LIMB REGIONlesion not detectedlesion not detected


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR9VISIT 82007-10-08
9

TUDY01

any body system domain409129Lesion 2Examination for AbnormalityLOWER LIMB REGIONlesion not detectedlesion not detected


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR9VISIT 82007-10-08

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Pros:
  1. Reusibility of the result location variables in other domains when needed.
  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. 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.
  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 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.
  5. This approach aligns the most with what happens in reality (the assessment of an image to find abnormalities).
Cons:
  1. 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.

Additional Questions to resolve:

  1. controlled terminology: finalize the tests for abnormality examination
  2. Team needs to think about the implication of this approach: does this mean if this is the way forward, we will no longer create "indicator" type of questions for abnormalities observed from an image?

    1. For example, for the existing test: Blood Regurgitation Indicator, results are Y/N. Using the new modeling approach, it would look like the following:

      Row

      STUDYID

      DOMAIN

      USUBJID

      SEQ

      		LNKID

      TEST

      LOC

      ORRES

      		STRESCResult LOC

      METHOD

      		EVEL

      VISITNUM

      VISIT

      TUDTC

      1

      TUDY01

      		any body system domain409121
      		Abnormality IndicatorLOWER LIMB REGIONYY
      		ECHOINVESTIGATOR2VISIT 12007-02-07
      2

      TUDY01

      		any body system domain409122
      		Examination for AbnormalityLOWER LIMB REGION

      blood regurgitation

      		blood regurgitationMitral ValveECHOINVESTIGATOR2VISIT 12007-02-07
      3

      TUDY03

      		any body system domain409121
      		Abnormality IndicatorLOWER LIMB REGIONNN
      		ECHOINVESTIGATOR2VISIT 12007-02-07
      4

      TUDY03

      		any body system domain409122
      		Examination for AbnormalityLOWER LIMB REGION

      blood regurgitation not detected

      		blood regurgitation not detectedMitral ValveECHOINVESTIGATOR2VISIT 12007-02-07









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