Representation of anyrusm in TU/TR

Case 1 - 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 scanning the subject from the chest to the 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? For "diagnostic procedures", especially imaging, 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 = chest), or does it mean that the purpose of the CT scan is to scan and create images of the chest? I think these are two different things.

Questions and Thoughts

Imaging modality for the CV-imaging project:

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.
We don't record PRLOC = chest for this procedure

Thransthoracic Echocardiogram (TTE):

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 as chest TTE.
Creates images of the heart.
We don't record PRLOC = Chest and upper abdomen for this procedure

Transesophageal Echocardiogram (TEE):

Done from the inside of the Esophagus.
Creates images of the heart.
We don't record PRLOC = Esophagus

Cine Angiography:

Done on the chest, again the probe is placed on top of the chest.
Creates images of the entire coronary artery system.

In addition, I just took my mother to have a Thyroid Ultrasound:

The ultrasound probe moved around her neck
Creates images of the thyroid gland. In this case would you argue that PRLOC is thyroid or neck?

Referring to Richard's email:

LOC in the interventions class is "Anatomical focus of an intervention - at which part of the body an intervention is being made". This also my understanding as well.

The "injection" intervention has an anatomical focus - the anatomical site of injection.
Percutaneous Coronary Intervention (also known as angioplasty with stent), has an anatomical location where the procedure occurs, intervenes and alters the structure of the location - i.e. in the RIGHT POSTERIOR DESCENDING ARTERY (PRLOC), the angioplasty breaks up the blockage and inserts a stent.

It is easy to pinpoint a location for invasive/treatment type interventions and this aligns with my understanding of how PRLOC should be used.

However, for "diagnostic imaging" procedures, where the imaging probe is placed (i.e. neck, chest, abdomen, head, etc.), is it relevant to record this information? Is this really the location where a intervention is "made"? is it even correct to place these values in PRLOC? (device attributes? maybe?)

so...my 2-cent is that diagnostic imaging procedures have no PRLOCs.

When we say "chest CT", it doesn't mean that a CT is done on the chest, it is a CT scan of the chest, it creates images of the chest, more precisely the thoracic region. "Chest" is the anatomical location for subsequent evaluations, aka --LOC for --TEST in a findings domain.

Same for abdominal and pelvic CT scans, MRIs.

Have I lose my god damn mind????

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pr.xpt

Row	STUDYID	DOMAIN	USUBJID	PRSEQ	PRTRT	PRLOC	VISIT
1	ABC	PR	ABC-456	1	MRI	Trunk?? or not needed period?	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

Dataset Debug Message

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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 only positive records. It doesn't allow the creation of a "pertinent negative" record. If I were to model case 1 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. The locations where an aneurysm is found, are mapped to TULOC instead of TURESLOC. 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	TULNKID	TUTEST	TUORRES	TULOC	TULAT	TUMETHOD	VISITNUM	VISIT	TUDTC
1	ABC	TU	ABC-456	1	Aneurysm 1	Aneurysm Identification	Target	Renal Artery	Left	MRI	1	BASELINE	2020-04-27
2	ABC	TU	ABC-456	2	Aneurysm 2	Aneurysm Identification	Target	Infrarenal Aorta		MRI	1	BASELINE	2020-04-27

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Case 2 - Subject has both TAA and AAA

The subject had a chest CT scan and an abdominal CT scan.

Are chest and abdomen really location of the procedure? See questions and comments under case 1

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pr.xpt

Row	STUDYID	DOMAIN	USUBJID	PRSEQ	PRTRT	PRLOC	VISIT
1	ABC	PR	ABC-123	1	CT SCAN	CHEST??? or not needed	BASELINE
2	ABC	PR	ABC-123	2	CT SCAN	ABDOMEN???? or not needed	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. 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	TU Result Loc 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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There are two leading, trailing, or non-breaking spaces in the dataset.
Please remove all paragraph and/or line breaks.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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.

tr.xpt

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

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

The dissected descending aorta (LNKID =Dissection 1) is classified based on the Stanford Aortic Dissection System as type B.

This test was originally created as a CVTEST, based on SDTMIG 3.4, this is considered as a grading scale and therefore should now be represented as CC/RS. Note the RSTEST still takes the original CV domain terminology naming convention, it does not comply with QRS rules.

rs.xpt

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKID	RSTEST	RSCAT	RSORRES	VISITNUM	VISIT	CVDTC
1	ABC	RS	ABC-123	3	Dissection 1	Stanford AoD Classification	STAN01	Stanford B	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.

After all this, i struggle with what values should go into TULOC. When a CT scans the chest, it produces cross-sectional images of the thorax. You can view the images in three angles: axial view (you are looking at the picture of the thorax from the direction of head to toe), the coronal view (you are looking at the images of the thorax as if you are standing in front of the person), sagittal view (you are looking at the picture of the thorax from the side). Hence TULOCs are populated with Thoracic Region and Abdominal Region. Especially in the axial view, as you move from cross-sectional images of the thorax to images of the abdomen, you are looking at sectioned images of the thoracic region to abdominal region, there is no mistake about it.

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Case 1 - Subject has AAA but TAA is not found

Case 2 - Subject has both TAA and AAA