Representation of anyrusm in TU/TR

Case 1 - Subject has both TAA and AAA

The subject had CT scans performed on the chest and abdomen.

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Row	STUDYID	DOMAIN	USUBJID	PRSEQ	PRTRT	PRLOC	VISIT
1	ABC	PR	ABC-123	1	CT SCAN	CHEST	BASELINE
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 1-2:	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.
Rows 3-4:	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.
Rows 5-6:	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.
Rows 7-8:	I examined the image of the abdominal region (test location) and found that the infrarenal aorta (result location) had dissected.

tu.xpt

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TUGRPID	TULNKID	TUTEST	TUORRES	TULOC	TUMETHOD	VISITNUM	VISIT	TUDTC	TURESLOC	TURESLOC Detail
1	ABC	TU	ABC-123	1	1	Aneurysm 1	Aneurysm Indicator	Y	Thoracic region	CT SCAN	1	BASELINE	2020-04-27
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
3	ABC	TU	ABC-123	3	2	Dissection 1	Dissection Indicator	Y	Thoracic region	CT SCAN	1	BASELINE	2020-04-27
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
5	ABC	TU	ABC-123	5	3	Aneurysm 2	Aneurysm Indicator	Y	Abdominal region	CT SCAN	1	BASELINE	2020-04-27
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
7	ABC	TU	ABC-123	7	4	Dissection 2	Dissection Indicator	Y	Abdominal region	CT SCAN	1	BASELINE	2020-04-27
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).
Row 2:	I measured the diameter of the infrarenal aortic (test location) aneurysm.
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
1	ABC	TR	ABC-123	1	Aneurysm 1	Aneurysm Diameter	6	cm	Thoracic Aorta	Aortic Arch to Descending aorta	CT SCAN	1	BASELINE	2020-04-27
2	ABC	TR	ABC-123	2	Aneurysm 2	Aneurysm Diameter	7	cm	Infrarenal aorta	proximal to the iliac bifurcation	CT SCAN	1	BASELINE	2020-04-27
4	ABC	TR	ABC-123	3	Dissection 1	Stanford AoD Classification	Stanford B		Descending aorta		CT SCAN	1	BASELINE	2020-04-27

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Questions and Thoughts

The results for TU, TUORRES = target, non-target, or new target. This convention was designed for tumor assessment. Target and non-target have very specific definitions depending on the tumor under study. Generally for solid tumor, according to RECIST:

Measurable lesions - lesions that can be accurately measured in at least one dimension with longest diameter 20 mm using conventional techniques or 10 mm with spiral CT scan.

All measurable lesions up to a maximum of five lesions per organ and 10 lesions in total, representative of all involved organs should be identified as target lesions and recorded and measured at baseline.

Non-measurable lesions - all other lesions, including small lesions (longest diameter <20 mm with conventional techniques or <10 mm with spiral CT scan), i.e., bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, cystic lesions, and also abdominal masses that are not confirmed and followed by imaging techniques.

All other lesions (or sites of disease) should be identified as non-target lesions and should also be recorded at baseline. Measurements of these lesions are not required, but the presence or absence of each should be noted throughout follow-up.

Since TU is also shared by Lesion Identification, to have a result as "target" is misleading and doesn't always apply to non-tumor settings. When you say there is a target aneurysm, what does that mean? Target for treatment and response evaluation? what is the criteria that makes it a target? Usually an aneurysm larger than 5cm requires surgery. Does that mean the ones that are smaller than 5 cm are considered "non-target"? and non-target for what? surgery not needed? The values for TU responses right now, doesn't make sense for non-tumor lesion identification process.

Case 2 - Subject has AAA but TAA is not found

The subject had a MRI performed on the torso (trunk).

Questions and Thoughts

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", 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, aka the thoracic region? I think this is confusing.

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Row	STUDYID	DOMAIN	USUBJID	PRSEQ	PRTRT	PRLOC	VISIT
1	ABC	PR	ABC-456	1	MRI	Trunk	BASELINE

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The MRI scan produced 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.
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).
Row 3:	I examined the image of the abdominal region (test location) and found an aneurysm in the infrarenal aorta (Result Loc).

tu.xpt

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TUGRPID	TULNKID	TUTEST	TUORRES	TULOC	TUMETHOD	VISITNUM	VISIT	TUDTC	TURESLOC	TURESLAT
1	ABC	TU	ABC-456	1			Aneurysm Indicator	N	Thoracic Region	MRI	1	BASELINE	2020-04-27
2	ABC	TU	ABC-456	2	1	Aneurysm 1	Aneurysm Indicator	Y	Abdominal Region	MRI	1	BASELINE	2020-04-27
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
4	ABC	TU	ABC-456	4	2	Aneurysm 2	Aneurysm Indicator	Y	Abdominal Region	MRI	1	BASELINE	2020-04-27
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).
Row 2:	I measured the diameter of the aneurysm in the Infrarenal Aorta (test location).

tr.xpt

Row	STUDYID	DOMAIN	USUBJID	TRSEQ	TRLNKID	TRTEST	TRORRES	TRORRESU	TRLOC	TRLAT	TRMETHOD	VISITNUM	VISIT	TRDTC
4	ABC	TR	ABC-456	1	Aneurysm 1	Aneurysm Diameter	3	cm	Renal Artery	Left	MRI	1	BASELINE	2020-04-27
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 identified tumors", is that it only allows the creation of a 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 represent the negative record for the Thoracic Region as shown above because an aneurysm is not identified in this region. Because when a large AAA is found, the chance of a TAA (or an aneurysm developed elsewhere) is high (the reverse holds true as well), in the presence of a diagnosed large AAA or TAA, it is recommended to also screen for the other. A TAA is synchronous if diagnosed within 2 years from the diagnosis of an AAA. All TAAs diagnosed at a later date were considered metachronous and must have had prior chest imaging that did not show the presence of TAA.

In the original DUKE data element, the responses provided for TAA and AAA, and all other types of aneurysms all have the responses: present, absent and unknown.

Row 1:	An aneurysm is present in the left renal artery.
Row 2:	An aneurysm is present in the Infrarenal Aorta

tu.xpt

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TUGRPID	TULNKID	TUTEST	TUORRES	TULOC	TULAT	TUMETHOD	VISITNUM	VISIT	TUDTC
3	ABC	TU	ABC-456	3	1	Aneurysm 1	Aneurysm Identification	Target	Renal Artery	Left	MRI	1	BASELINE	2020-04-27
5	ABC	TU	ABC-456	5	2	Aneurysm 2	Aneurysm Location/Identification	Target	Infrarenal Aorta		MRI	1	BASELINE	2020-04-27

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Questions and Thoughts

Coronary angiography:

Done on the chest area, the probe rotates around the chest of the subject, but there is no such a thing as "chest Coronary angiography", it is simply called Coronary angiography.
Creates images of the entire coronary artery system

Thoracic Echocardiogram (TEE):

Done on the chest and upper abdominal wall. The transducer is placed on various parts of the chest and upper belly to get different views of the heart. Again, there is no such a thing chest TEE.
Creates images of the heart

Transesophageal Echocardiogram (TEE):

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Case 1 - Subject has both TAA and AAA

Case 2 - Subject has AAA but TAA is not found