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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. The ability to create a negative record when the abnormality is no longer observed.
  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 examinationdetails for the test = Examination for Abnormality
  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? We need to ask ourselves: are there really "pre-specified findings" from observing an image. Did you plan to find an aneurysm from the chest CT scan? Did you plan to find mitral valve calcification and stenosis, as well as mitral valve regurgitation? You planned for a procedure, chest CT scan, the abnormalities are what you find. Hence, is it really correct to create the indicator question: Aneurysm Indicator? Blood Regurgitation Indicator?
    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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