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Case 1 - Subject has
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both TAA and AAA
The subject had a
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chest CT scan and an abdominal CT scan.
Are chest and abdomen really location of the procedure?
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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. | ||
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:
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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 took my mother to have a Thyroid Ultrasound:
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.
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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An evaluator examines the images of 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 TAAproduced 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.
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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). | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRLNKID | TRTEST | TRORRES | TRORRESU | TRLOC | TRLAT | TRMETHOD | VISITNUM | VISIT | TRDTC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1 | ABC | TR | ABC-456 | 1 | Aneurysm 1 | Aneurysm Diameter | 3 | cm | Renal Artery | Left | MRI | 1 | BASELINE | 2020-04-27 | 2 | ABC | TR | ABC-456 | 2 | Aneurysm 2 | Aneurysm Diameter | 5 | cm | Infrarenal Aorta | MRI | 1 | BASELINE | 2020-04-27 |
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.
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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.
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Row 1: | An aneurysm is present in the left renal artery. | Row 2: | An aneurysm is present in the Infrarenal Aorta
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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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title | cv.xpt |
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Name | PR |
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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.
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Again, is there a PRLOC for the MRI procedure? 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? |
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Row
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STUDYID
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DOMAIN
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USUBJID
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PRTRT
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VISIT
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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.
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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.|||||||||||||||||||||||||||
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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.
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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.
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.
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKID | RSTEST | RSCAT | RSORRES | VISITNUM | VISIT | CVDTC | |||||||||||||||||||||||||||||||||||||||
1 | ABC | RS | ABC-123 | 3 | Dissection 1 | Stanford AoD Classification | Hiratzka Dissection 2010 | Stanford B | 1 | BASELINE | 2020-04-27 | |||||||||||||||||||||||||||||||||||||||
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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.
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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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