How do you represent the complex anatomy of a lesion’s location, such as : “A lesion is in the segment of the popliteal artery above the knee, in the femoral-popliteal major arterial vessel system, of the left leg.”
This example shows how to model complex locations using a combination of location-related TESTs and location variables.
This is probably as complicated for modeling anatomy as it goes, location identification for most abnormality may not require this level of detail, i.e. the aneurysm example.
Approach 1: using result location variables
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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 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 | 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 | 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 |
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| 2 | TUDY01 | TU | 40912 | 2 |
| Limb with Lesion Location Identification | LOWER LIMB REGION | IDENTIFIED | IDENTIFIED | LEG | LEFT |
| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 3 | TUDY01 | TU | 40912 | 3 |
| Vessel with Lesion Location Identification | LOWER LIMB REGION | IDENTIFIED | IDENTIFIED | FEMORO-POPLITEAL PERIPHERAL ARTERY | LEFT |
| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 4 | TUDY01 | TU | 40912 | 4 | Lesion 1 | Lesion Location Identification | LOWER LIMB REGION | IDENTIFIED | IDENTIFIED | POPLITEAL ARTERY | LEFT | BELOW THE KNEE | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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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.
- A combination of location-related tests and location variables help to better support complex anatomical data mapping.
- Clarity of data representation
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| Cons: | - there is only one result associated with the location questions.
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| Vote: |
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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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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 limb that contains lesion is the leg. |
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| Row 3: | Shows the leg that contains the lesion is the left one. |
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| Row 4: | Shows the vessel that contains the lesion is the femerol-popliteal peripheral artery. |
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| Row 5: | Shows the femerol-popliteal peripheral artery that contains the lesion is the left one. |
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| Row 6: | Shows the specific lesion is in the popliteal artery. |
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| Row 7: | Shows the popliteal artery that contains the lesion is the left one. |
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| Row 8: | Shows the lesion is in the segment of the left popliteal artery below the knee. |
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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 | TUGRPID | TUTEST | TULOC | TUORRES | TUMETHOD | TUEVEL | VISITNUM | VISIT | TUDTC |
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| 1 | TUDY01 | TU | 40912 | 1 |
| Lesion Indicator | Lower limb region | Y | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 2 | TUDY01 | TU | 40912 | 2 | 1 | Limb with Lesion Location Identification | Lower limb region | Leg | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 3 | TUDY01 | TU | 40912 | 3 | 1 | Limb with Lesion location Laterality Identification | Leg | Left | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 4 | TUDY01 | TU | 40912 | 4 | 2 | Vessel with Lesion Location Identification | Lower limb region | Femerol-popliteal peripheral artery | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 5 | TUDY01 | TU | 40912 | 5 | 2 | Vessel with Lesion Location Laterality Identification | Femerol-popliteal peripheral artery | left | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 6 | TUDY01 | TU | 40912 | 6 | 3 | Lesion Location Identification | Lower limb region | popliteal artery | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 7 | TUDY01 | TU | 40912 | 7 | 3 | Lesion Location Laterality Identification | popliteal artery | left | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 8 | TUDY01 | TU | 40912 | 8 | 3 | Lesion Location Detail Identification | left popliteal artery | below the knee | 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
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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.
- 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.
- Just a lot of rows...
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| Vote: |
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Approach 3: taking a similar approach as SEND in MI domain modeling where MI test = microscopic examination
I think Diane had proposed this approach before but it didn't go anywhere?
| Dataset wrap |
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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 | 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 |
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| 2 | TUDY01 | TU | 40912 | 2 |
| Examination | LOWER LIMB REGION | Limb with lesion | Limb with lesion | LEG | LEFT |
| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 3 | TUDY01 | TU | 40912 | 3 |
| Examination | LOWER LIMB REGION | Vessel with lesion | Vessel with lesion | FEMORO-POPLITEAL PERIPHERAL ARTERY | LEFT |
| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 4 | TUDY01 | TU | 40912 | 4 | Lesion 1 | Examination | LOWER LIMB REGION | Lesion | Lesion | POPLITEAL ARTERY | LEFT | BELOW THE KNEE | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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