You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 24 Next »

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:

  1. 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.
  2. Creates images of the entire coronary artery system.
  3. We don't record PRLOC = chest for this procedure

Thransthoracic Echocardiogram (TTE):

  1. 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.
  2. Creates images of the heart.
  3. We don't record PRLOC = Chest and upper abdomen for this procedure

Transesophageal Echocardiogram (TEE):

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

Cine Angiography:

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

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

  1. The ultrasound probe moved around her neck
  2. 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????


$titleHtml

pr.xpt

Row

STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

PRLOC

VISIT

 1  ABCPR  ABC-4561MRITrunk?? or not needed period?
BASELINE
$warningHtml

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

tu.xpt

Row

STUDYID

DOMAIN

USUBJID

TUSEQ

TUGRPID

TULNKID

TUTEST

TUORRES

TULOC

TUMETHOD

VISITNUM

VISIT

TUDTC


TURESLOCTURESLAT
1ABCTUABC-4561

Aneurysm IndicatorNThoracic RegionMRI1BASELINE2020-04-27


2

ABC

TUABC-45621Aneurysm 1Aneurysm IndicatorYAbdominal RegionMRI1BASELINE2020-04-27


3ABCTUABC-45631Aneurysm 1Aneurysm Location/Identification

Target?

Identified

Abdominal RegionMRI1BASELINE2020-04-27
Renal ArteryLeft
4ABCTUABC-45642Aneurysm 2Aneurysm IndicatorYAbdominal RegionMRI1BASELINE2020-04-27


5ABCTUABC-45652Aneurysm 2Aneurysm Location/Identification

Target?

Identified

Abdominal RegionMRI1BASELINE2020-04-27
Infrarenal Aorta

Dataset Debug Message

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 in the left renal artery (test location).
Row 2:I measured the diameter of the aneurysm in the Infrarenal Aorta (test location).

tr.xpt

tr.xpt

Row

STUDYID

DOMAIN

USUBJID

TRSEQTRLNKID

TRTEST

TRORRES

TRORRESU

TRLOC

TRLAT

TRMETHOD

VISITNUM

VISIT

TRDTC

4ABCTRABC-4561Aneurysm 1Aneurysm Diameter3cmRenal ArteryLeftMRI1BASELINE2020-04-27
5ABCTRABC-4562Aneurysm 2Aneurysm Diameter5cmInfrarenal Aorta
MRI1BASELINE2020-04-27
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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

tu.xpt

Row

STUDYID

DOMAIN

USUBJID

TUSEQTULNKID

TUTEST

TUORRES

TULOC

TULAT

TUMETHOD

VISITNUM

VISIT

TUDTC

1ABCTUABC-4561Aneurysm 1Aneurysm Identification

Target

Renal ArteryLeftMRI1BASELINE2020-04-27
2ABCTUABC-4562Aneurysm 2Aneurysm IdentificationTargetInfrarenal Aorta
MRI1BASELINE2020-04-27

Dataset Debug Message

There is a leading, trailing, or non-breaking space in the dataset.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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

$titleHtml

pr.xpt

Row

STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

PRLOC

VISIT

 1  ABCPR  ABC-1231CT SCANCHEST??? or not needed
BASELINE
2  ABCPR  ABC-1232CT SCANABDOMEN???? or not needed
BASELINE
$warningHtml
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

tu.xpt

Row

STUDYID

DOMAIN

USUBJID

TUSEQ

TUGRPID

TULNKID

TUTEST

TUORRES

TULOC

TUMETHOD

VISITNUM

VISIT

TUDTC


TURESLOCTU Result Loc Detail
1ABCTUABC-12311Aneurysm 1Aneurysm IndicatorYThoracic region

CT SCAN

1BASELINE2020-04-27


2ABCTUABC-12321Aneurysm 1Aneurysm Location/Identification

Target?

Identified

Thoracic region

CT SCAN

1BASELINE2020-04-27
Thoracic AortaAortic Arch to Descending aorta
3ABCTUABC-12332Dissection 1Dissection IndicatorYThoracic region

CT SCAN

1BASELINE2020-04-27


4ABCTUABC-12342Dissection 1

Dissection Location/Identification

Target?

Identified

Thoracic region

CT SCAN

1BASELINE2020-04-27
Descending aorta
5ABCTUABC-12353Aneurysm 2Aneurysm IndicatorYAbdominal region

CT SCAN

1BASELINE2020-04-27


6ABCTUABC-12363Aneurysm 2Aneurysm Location/Identification

Target?

Identified

Abdominal region

CT SCAN

1BASELINE2020-04-27
Infrarenal aortaproximal to the iliac bifurcation
7ABCTUABC-12374Dissection 2Dissection IndicatorYAbdominal regionCT SCAN1BASELINE2020-04-27


8ABCTUABC-12384Dissection 2

Dissection Location/Identification

Target?

Identified

Abdominal region

CT SCAN

1BASELINE2020-04-27
Infrarenal aortaproximal to the iliac bifurcation

Dataset Debug Messages

  • 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

tr.xpt

Row

STUDYID

DOMAIN

USUBJID

TRSEQ

TRLNKID

TRTEST

TRORRES

TRORRESU

TRLOC

TRLOCDTL

TRMETHOD

VISITNUM

VISIT

CVDTC

1ABCTRABC-1231Aneurysm 1Aneurysm Diameter6cmThoracic AortaAortic Arch to Descending aortaCT SCAN1BASELINE2020-04-27
2ABCTRABC-1232Aneurysm 2Aneurysm Diameter7cmInfrarenal aortaproximal to the iliac bifurcationCT SCAN1BASELINE2020-04-27
$warningHtml

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

rs.xpt

Row

STUDYID

DOMAIN

USUBJID

RSSEQ

RSLNKID

RSTEST

RSCAT

RSORRES

VISITNUM

VISIT

CVDTC

1ABCRSABC-1233Dissection 1Stanford AoD ClassificationHiratzka Dissection 2010Stanford B1BASELINE2020-04-27
$warningHtml

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.

  • No labels