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The subject had a chest CT scan and an abdominal CT scan.
Are chest and abdomen really locations of the procedure?
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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. |
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Imaging modality for the CV-imaging project: Coronary angiography:
Thransthoracic Echocardiogram (TTE):
Transesophageal Echocardiogram (TEE):
Cine Angiography:
In addition, i just recently took a family member to have a Thyroid Ultrasound:
Referring to Richard M'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.
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/made 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. |
The subject had a chest CT scan and an abdominal CT scan.
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Name | PR |
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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 locations. Note for viewing simplicity, some variables are omitted from the table below.
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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 locations. Note for viewing simplicity, some variables are omitted from the table below.
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The dissected descending aorta (LNKID =Dissection 1) is classified based on the Stanford Aortic Dissection System as type B.
Note: This test was originally created as a CVTEST, based on SDTMIG 3.4, this is now 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.
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Info | 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 thoracic aortic aneurysm where LNKID = Aneurysm 1. | |||||||||||
Row 2: | I measured the diameter of the abdominal aortic aneurysm where LNKID = Aneurysm 2. | |||||||||||
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRLNKID | TRTEST | TRORRES | TRORRESU | TRMETHOD | VISITNUM | VISIT | CVDTC |
1 | ABC | TR | ABC-123 | 1 | Aneurysm 1 | Diameter | 6 | cm | CT SCAN | 1 | BASELINE | 2020-04-27 |
2 | ABC | TR | ABC-123 | 2 | Aneurysm 2 | Diameter | 7 | cm | CT SCAN | 1 | BASELINE | 2020-04-27 |
The dissected descending aorta (LNKID =Dissection 1) is classified based on the Stanford Aortic Dissection System as type B.
Note: This test was originally created as a CVTEST, based on SDTMIG 3.4, this is now 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.
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title | cv.xpt |
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Name | RS |
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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.
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.
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 that scanned his torso, from chest to abdomen.
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Again, is there a PRLOC for the MRI procedure? You are scanning the subject from the chest to the abdomen. |
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The MRI scan produced cross-sectional images of 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, and an aneurysm in the left renal artery, but the absence of TAA.
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.
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RSORRES
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CVDTC
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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.
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.
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 that scanned his torso, from chest to abdomen.
Info | ||
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| ||
Again, is there a PRLOC for the MRI procedure? You are scanning the subject from the chest to the abdomen. |
...
title | cv.xpt |
---|---|
Name | PR |
...
Row
...
STUDYID
...
DOMAIN
...
USUBJID
...
PRTRT
...
VISIT
...
The MRI scan produced cross-sectional images of 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, and an aneurysm in the left renal artery, but the absence of TAA.
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.
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The problem with the way TU is set up now, which is originally designed for tumor identification, and you only care about "already identified tumors", is that it only allows the creation of positive records. 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. This is also in part, due to the fact that the location where an object is found, is mapped to PRLOC instead of TULOC, thusly not allowing the representation of imaging location in findings.
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.
The example below models TAA and AAA according to the current TU domain structure. Note i am unable to map the negative identification record.
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The problem with the way TU is set up now, which is originally designed for tumor identification, and you only care about "already identified tumors", is that it only allows the creation of positive records. 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. This is also in part, due to the fact that the location where an object is found, is mapped to PRLOC instead of TULOC, thusly not allowing the representation of imaging location in findings.
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.
The example below models TAA and AAA according to the current TU domain structure. Note i am unable to map the negative identification record.
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title | cv.xpt |
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Name | TU |
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STUDYID
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DOMAIN
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USUBJID
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TUTEST
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TUORRES
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TULOC
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TUMETHOD
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VISITNUM
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VISIT
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TUDTC
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Target
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What goes into TULOC?
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 chest/thorax and everything in it. You can view the images in three angles: a) axial view (you are looking at the picture of the thorax from the direction of head to toe), b) the coronal view (you are looking at the images of the thorax as if you are standing in front of the person), c) sagittal view (you are looking at the picture of the thorax from the side). Hence TULOCs are populated with Thoracic Region and Abdominal Region for now. 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 which region you are looking at because the anatomy of both regions are so different and clearly sperpated. I think it is not wrong to populate TULOC with chest and abdomen as well, they are just not the most precise anatomical terms.
Info | ||
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Imaging modality for the CV-imaging project: Coronary angiography:
Thransthoracic Echocardiogram (TTE):
Transesophageal Echocardiogram (TEE):
Cine Angiography:
In addition, i just recently took a family member to have a Thyroid Ultrasound:
Referring to Richard M'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.
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 this really the location where a intervention is "made"? |
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What goes into TULOC?
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 chest/thorax and everything in it. You can view the images in three angles: a) axial view (you are looking at the picture of the thorax from the direction of head to toe), b) the coronal view (you are looking at the images of the thorax as if you are standing in front of the person), c) sagittal view (you are looking at the picture of the thorax from the side). Hence TULOCs are populated with Thoracic Region and Abdominal Region for now. 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 which region you are looking at because the anatomy of both regions are so different and clearly sperpated. I think it is not wrong to populate TULOC with chest and abdomen as well, they are just not the most precise anatomical terms.
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