Case 1 - Subject has both TAA and AAA
The subject had CT scans performed on the chest and abdomen.
Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRTRT | PRLOC | VISIT |
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| 1 | ABC | PR | ABC-123 | 1 | CT SCAN | CHEST | BASELINE |
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| 2 | ABC | PR | ABC-123 | 2 | CT SCAN | ABDOMEN | BASELINE |
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An evaluator examines the images of the thoracic and abdominal regions produced by the CT scan and decides whether TAA and AAA are present as well as their location. Modeling both TAA and AAA in the CV domain, note for viewing simplicity, some variables are omitted from the table below.
| Rows 1 and 2: | I examined the image of the thoracic region (test location) and found an aneurysm in the Thoracic Aorta (result location) spanning from the aortic arch to the descending aorta (result location detail). In this case result location detail further qualifies both ORRES and RESLOC, hence this is a variable qualifier. |
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| Rows 3 and 4: | I examined the image of the thoracic region (test location) and found that the descending aorta (result location) had dissected (the artery is tore and a false lumen had formed), most likely due to the enormous pressure caused by the large aneurysm in this area. |
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| Rows 5 and 6: | I examined the image of the abdominal region (test location) and found an aneurysm in the infrarenal aorta (result location), proximal to the iliac bifurcation (result location detail). In this case result location detail is a variable qualifier for the result, I am trying to say that the aneurysm is located in the segment of the infrarenal aorta closer (proximal) to the iliac bifurcation. |
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| Rows 7 and 8: | I examined the image of the abdominal region (test location) and found that the infrarenal aorta (result location) had dissected. |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUGRPID | TULNKID | TUTEST | TUORRES | TULOC | TUMETHOD | VISITNUM | VISIT | TUDTC |
| TURESLOC
| TURESLOC Detail |
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| 1 | ABC | TU | ABC-123 | 1 | 1 | Aneurysm 1 | Aneurysm Indicator | Y | Thoracic region | CT SCAN | 1 | BASELINE | 2020-04-27 |
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| 2 | ABC | TU | ABC-123 | 2 | 1 | Aneurysm 1 | Aneurysm Location/Identification | Target? Identified | Thoracic region | CT SCAN | 1 | BASELINE | 2020-04-27 |
| Thoracic Aorta | Aortic Arch to Descending aorta |
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| 3 | ABC | TU | ABC-123 | 3 | 2 | Dissection 1 | Dissection Indicator | Y | Thoracic region | CT SCAN | 1 | BASELINE | 2020-04-27 |
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| 4 | ABC | TU | ABC-123 | 4 | 2 | Dissection 1 | Dissection Location/Identification | Target? Identified | Thoracic region | CT SCAN | 1 | BASELINE | 2020-04-27 |
| Descending aorta |
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| 5 | ABC | TU | ABC-123 | 5 | 3 | Aneurysm 2 | Aneurysm Indicator | Y | Abdominal region | CT SCAN | 1 | BASELINE | 2020-04-27 |
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| 6 | ABC | TU | ABC-123 | 6 | 3 | Aneurysm 2 | Aneurysm Location/Identification | Target? Identified | Abdominal region | CT SCAN | 1 | BASELINE | 2020-04-27 |
| Infrarenal aorta | proximal to the iliac bifurcation |
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| 7 | ABC | TU | ABC-123 | 7 | 4 | Dissection 2 | Dissection Indicator | Y | Abdominal region | CT SCAN | 1 | BASELINE | 2020-04-27 |
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| 8 | ABC | TU | ABC-123 | 8 | 4 | Dissection 2 | Dissection Location/Identification | Target? Identified | Abdominal region | CT SCAN | 1 | BASELINE | 2020-04-27 |
| Infrarenal aorta | proximal to the iliac bifurcation |
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| Row 1: | I measured the diameter of the aneurysm from aortic arch to the descending aorta (test location). |
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| Row 2: | I measured the diameter of the infrarenal aortic (test location) aneurysm. |
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| Row 3: | The dissected descending aorta (test location) is classified based on the Stanford Aortic Dissection System as type B. |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRLNKID | TRTEST | TRORRES | TRORRESU | TRLOC | TRLOCDTL | TRMETHOD | VISITNUM | VISIT | CVDTC |
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| 1 | ABC | CV | ABC-123 | 1 | Aneurysm 1 | Aneurysm Diameter | 6 | cm | Thoracic Aorta | Aortic Arch to Descending aorta | CT SCAN | 1 | BASELINE | 2020-04-27 |
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| 2 | ABC | CV | ABC-123 | 2 | Aneurysm 2 | Aneurysm Diameter | 7 | cm | Infrarenal aorta | proximal to the iliac bifurcation | CT SCAN | 1 | BASELINE | 2020-04-27 |
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| 4 | ABC | CV | ABC-123 | 3 | Dissection 1 | Stanford AoD Classification | Stanford B |
| Descending aorta |
| CT SCAN | 1 | BASELINE | 2020-04-27 |
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Case 2 - Subject has AAA but TAA is not found
The subject had a MRI performed on the torso (trunk).
Question:
- I wonder what the LOC truly is in this procedure, or whether you need a value in PRLOC at all, because essentially, you are doing a Chest MRI, followed by abdominal MRI (or vise versa) - the MRI scans and take cross-sectional pictures of your chest and abdomen. If the scanning is done on the same day in one visit, would you consider the scan of the chest a separate procedure from the scan of the abdomen? This is why for diagnostic procedures (not invasive procedure), I think the location where the procedure is done is irrelevant. When we say Chest CT, or Chest MRI, does this mean the CT scan is done on the chest (hence PRLOC), or does it mean that the purpose of the CT scan is to scan and create images of the chest? I think this is where the confusion is.
Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRTRT | PRLOC | VISIT |
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| 1 | ABC | PR | ABC-456 | 1 | MRI | Trunk | BASELINE |
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The MRI scan produced many cross-sectional images about the thoracic and abdominal regions of the subject. The evaluator then examined the MRI images of the thoracic region and abdominal region, and found the presence of a large AAA, but the absence of TAA.
| Row 1: | I examined the MRI image of the thoracic region (test location) and didn't find the presence of an aneurysm. |
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| Row 2: | I examined the MRI image of the abdominal region (test location) and found an aneurysm in the left (Result LAT) renal artery (Result Loc). |
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| Row 3: | I examined the image of the abdominal region (test location) and found an aneurysm in the infrarenal aorta (Result Loc). |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUGRPID | TULNKID | TUTEST | TUORRES | TULOC | TUMETHOD | VISITNUM | VISIT | TUDTC |
| TURESLOC
| TURESLAT |
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| 1 | ABC | TU | ABC-456 | 1 |
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| Aneurysm Indicator | N | Thoracic Region | MRI | 1 | BASELINE | 2020-04-27 |
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| 2 | ABC | TU | ABC-456 | 2 | 1 | Aneurysm 1 | Aneurysm Indicator | Y | Abdominal Region | MRI | 1 | BASELINE | 2020-04-27 |
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| 3 | ABC | TU | ABC-456 | 3 | 1 | Aneurysm 1 | Aneurysm Location/Identification | Target? Identified | Abdominal Region | MRI | 1 | BASELINE | 2020-04-27 |
| Renal Artery | Left |
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| 4 | ABC | TU | ABC-456 | 4 | 2 | Aneurysm 2 | Aneurysm Indicator | Y | Abdominal Region | MRI | 1 | BASELINE | 2020-04-27 |
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| 5 | ABC | TU | ABC-456 | 5 | 2 | Aneurysm 2 | Aneurysm Location/Identification | Target? Identified | Abdominal Region | MRI | 1 | BASELINE | 2020-04-27 |
| Infrarenal Aorta |
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| Row 1: | I measured the diameter of the aneurysm in the left renal artery (test location). |
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| Row 2: | I measured the diameter of the aneurysm in the Infrarenal Aorta (test location). |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRLNKID | TRTEST | TRORRES | TRORRESU | TRLOC | TRLAT | TRMETHOD | VISITNUM | VISIT | TRDTC |
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| 4 | ABC | TR | ABC-456 | 1 | Aneurysm 1 | Aneurysm Diameter | 3 | cm | Renal Artery | Left | MRI | 1 | BASELINE | 2020-04-27 |
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| 5 | ABC | TR | ABC-456 | 2 | Aneurysm 2 | Aneurysm Diameter | 5 | cm | Infrarenal Aorta |
| MRI | 1 | BASELINE | 2020-04-27 |
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The problem with the way TU is set up now, which is originally designed for tumor identification and response evaluation, and you only care about "already identifed tumor masses", is that it only allows the creation of an positive record. It doesn't allow the creation of a "pertinent negative" record. If I were to model case 2 in TU the way TU is designed now, I would lose the ability to present the negative record for Thoracic Region as shown above because an aneurysm is not identified in this region.
| Row 1: | An aneurysm is present in the left renal artery. |
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| Row 2: | An aneurysm is present in the Infrarenal Aorta |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUGRPID | TULNKID | TUTEST | TUORRES | TULOC | TULAT | TUMETHOD | VISITNUM | VISIT | TUDTC |
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| 3 | ABC | TU | ABC-456 | 3 | 1 | Aneurysm 1 | Aneurysm Identification | Target? Identified | Renal Artery | Left | MRI | 1 | BASELINE | 2020-04-27 |
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| 5 | ABC | TU | ABC-456 | 5 | 2 | Aneurysm 2 | Aneurysm Location/Identification | Target? Identified | Infrarenal Aorta |
| MRI | 1 | BASELINE | 2020-04-27 |
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