This example shows how to model complex locations using a combination of location-related TESTs and location variables.
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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 said abnormality is mapped to RESLOC.
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| Rowcaps |
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| Row 1: | Shows one or more lesions have been identified in the lower limb region at Visit 1. |
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| Row 2: | Shows |
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the limb that contains | lesion 1 is found in the left |
leg| popliteal artery, below the knee. | | Row 3: | Shows |
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the major vessel that contains a the left femoro-popliteal peripheral | found in the right femoral artery. | | Row 4: | Shows one or more lesions have been identified in the lower limb region at Visit 4 |
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| Row 5: | Shows after treatment, lesion |
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is found in the left popliteal artery, in the segment below the knee. Note a TULNKID is created for row 4 where TULNKID = Lesion 1. This --LNKID is used to connect to the lesion severity assessment in CV.| 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. |
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| Row 7: | Shows there are no more lesions identified in the lower limb region at Visit 8. |
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| Row 8: | Shows after treatments, lesion 1 is not detected, hence RESLOC is not populated, suggesting the treatment had worked. |
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| Row 9: | Shows after treatments, lesion 2 is not detected, hence RESLOC is not populated, suggesting the treatment had worked. |
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| Dataset2 |
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| | Dataset2 |
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| hi1style | yellow |
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| hi2 | 7 |
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| hi1 | 6 |
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| hi2style | aqua |
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| tableid | TU1 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTEST | TULOC | TULAT | TULOCDTL | TUORRES | TUSTRESC | TU Result LOC | TU Result LAT | TU Result LOCDTL | TUMETHOD | TUEVEL | VISITNUM | VISIT | TUDTC |
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| 1 | TUDY01 | TU | 40912 | 1 |
| Lesion Indicator | LOWER LIMB REGION | Y | Y |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | | 2 | TUDY01 | TU | 40912 | 2Limb with Lesion Location Identification | Lesion 1 | Examination for Abnormality | LOWER LIMB REGION | LOCATEDlesionLOCATED | lesionLEG | POPLITEAL ARTERY | LEFT | BELOW THE KNEE | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | | 3 | TUDY01 | TU | 40912 | 3Vessel with Lesion Location Identification | Lesion 2 | Examination for Abnormality | LOWER LIMB REGION | LOCATEDlesion | LOCATED | lesion | FEMORAL FEMORO-POPLITEAL PERIPHERAL ARTERY | LEFTRIGHT |
| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | | 4 | TUDY01 | TU | 40912 | 4 |
| Lesion Indicator | LOWER LIMB REGION | Y | Y |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 5 | VISIT 4 | 2007-04-07 | | 5 | TUDY01 | TU | 40912 | 5 | Lesion 1 | Examination for Abnormality | Lesion LOWER LIMB REGION | lesion not detected | lesion not detected |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 5 | VISIT 4 | 2007-04-07 | | 6 | TUDY01 | TU | 40912 | 6 | Lesion 2 | Examination for Abnormality | Location Identification | LOWER LIMB REGION | LOCATEDlesion | LOCATEDlesion | POPLITEAL FEMORAL ARTERY | LEFT | BELOW KNEERIGHT |
| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 25 | VISIT | 14 | 2007- | 0204-07 |
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| Dataset wrap |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | CVLNKID | CVTEST | CVCAT | CVORRES | VISITNUM | VISIT | RSDTC |
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| 1 | TUDY01 | CV | 40912 | 1 | Lesion 1 | Lesion Severity | Sponsor-defined Criteria | Severe | 2 | VISIT 1 | 2007-02-07 |
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| | 7 | TUDY01 | TU | 40912 | 7 |
| Lesion Indicator | LOWER LIMB REGION | N | N |
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| 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 |
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| 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 |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 9 | VISIT 8 | 2007-10-08 |
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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 -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). We all like this better
 yay win~
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| 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.
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| Vote: | |
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Approach 1: using result location variables
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| Dataset2rowcaps |
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| Row 1: | Shows one or more lesions have been identified in the lower limb region. |
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| Row 2: | Shows the limb that contains lesion is the left leg. |
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| Row 3: | Shows the major vessel that contains a lesion is the left femoro-popliteal peripheral artery. |
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| 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. |
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| Dataset2 |
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| hi1style | yellow |
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| hi2 | 4,5 |
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| hi1 | 2,3 |
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| hi3 | 6,7,8 |
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| hi2style | aqua |
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| hi3style | pink |
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| tableid | TU1 |
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| Row | STUDYID | DOMAIN | USUBJID | TUSEQ |
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TUGRPID| TULNKID | TUTEST | TULOC | TUORRES | TU Result LOC | TU Result LAT | TU Result LOCDTL | TUMETHOD | TUEVEL | VISITNUM | VISIT | TUDTC |
| TURLGFFL |
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| 1 | TUDY01 | TU | 40912 | 1 |
| Lesion Indicator |
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Lower limb region| LOWER LIMB REGION | Y |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| | 2 | TUDY01 | TU | 40912 | 2 | Lesion 1 |
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Limb with | Lesion Location Identification |
Lower limb region | Leg | LOWER LIMB REGION | IDENTIFIED | POPLITEAL ARTERY | LEFT | ABOVE KNEE | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| | 3 | TUDY01 | TU | 40912 | 3 | Graft Lesion 1 |
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Limb with location Laterality Leg | Left| LOWER LIMB REGION | IDENTIFIED | LEFT FEMORO-POPLITEAL | LEFT | PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
| Y |
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| Nsvmeta |
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| Variable | Label | Type | Role | Origin |
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| TURLGFFL | Result location is Graft Flag | text | Non-Standard Record Qualifier | CRF |
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| Pros: | - Reusibility of the result location variables in other domains.
- 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.
- Clarity of data representation
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| Cons: | - "Identified" is a pre-specified result, this just seems wrong.
- 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.
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| Vote: | |
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Approach 2: representing lesion locations as result values
| Dataset wrap |
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| Rowcaps |
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| Row 1: | Shows one or more lesions have been identified in the lower limb region. |
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| Row 2: | Shows the lesion is in the POPLITEAL ARTERY. |
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| Row 3: | Shows the lesion is in the left POPLITEAL ARTERY. |
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| Row 4: | Shows the lesion is in the left POPLITEAL ARTERY, in the segment above the knee. |
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| Row 5: | Shows the lesion is in the LEFT FEMORO-POPLITEAL GRAFT. |
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| Row 6: | Shows the lesion is in the LEFT FEMORO-POPLITEAL GRAFT, PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT. |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTEST | TULOC | TULAT | TUORRES | TUMETHOD | TUEVEL | VISITNUM | VISIT | TUDTC |
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| 1 | TUDY01 | TU | 40912 |
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| 1 |
| Lesion Indicator | LOWER LIMB REGION |
| Y | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | | 2 | TUDY01 | TU | 40912 |
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4Vessel with | Lesion 1 | Lesion Location Identification |
Lower limb region | Femerol-popliteal peripheral artery| LOWER LIMB REGION |
| POPLITEAL ARTERY | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
552Vessel with | Lesion Location Laterality Identification |
Femerol-popliteal peripheral artery | left| POPLITEAL ARTERY |
| LEFT | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
663| Lesion 1 | Lesion Location Detail Identification |
Lower limb region | popliteal artery | POPLITEAL ARTERY | LEFT | ABOVE KNEE | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
773| Graft Lesion 1 | Lesion Location |
Laterality popliteal artery | left| LOWER LIMB REGION |
| LEFT FEMORO-POPLITEAL GRAFT | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
883| Graft Lesion 1 | Lesion Location Detail Identification |
left popliteal artery | above the knee| LEFT FEMORO-POPLITEAL GRAFT |
| PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| Pros: | - lesion location, location laterality and location details are represented as separate TUTESTs - allowing different results.
- Represent Graft as part of the ORRES, instead of using a NSV.
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| Cons: | - 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:
- xxx location identification
- xxx location laterality identification
- xxx location directionality identification
- xxx location portot identification
- xxx location detail identification
- Reusibility in other domains is limited, seeing as lesion identification should all be mapped to TU.
- 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.
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| Vote: | |
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