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Case 1 - Subject has
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The subject had CT scans performed on the chest and abdomen.
AAA but TAA is not found
The subject had a MRI performed on the torso (trunk).
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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. |
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Imaging modality for the CV-imaging project: Coronary angiography:
Thoracic Echocardiogram (TEE):
Transesophageal Echocardiogram (TEE):
Cine Angiography:
A chest CT 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. If PRTRT = CT Scan, PRLOC = Chest. The way I read this is that the CT scan is done on the chest, which doesn't make sense. An abdominal CT doesn't mean a CT done on the abdomen, it is a CT scan of the abdomen, it creates images of the abdominal region. |
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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 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.
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Case 2 - Subject has both TAA and AAA
The subject had a chest CT scan and abdominal scan.
Are chest and abdomen really location of the procedure? See questions and comments under Case 2.case 1
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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.
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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 performed on the torso (trunk).
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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 doing a Chest MRI, followed by abdominal MRI (or vise versa) - the MRI scans and takes 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. |
| Info | ||
|---|---|---|
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Imaging modality for the CV-imaging project: Coronary angiography:
Thoracic Echocardiogram (TEE):
Transesophageal Echocardiogram (TEE):
Cine Angiography:
A chest CT doesn't mean that a CT is done on the chest (not PRLOC), it is a CT scan that creates images of the chest, more precisely the thoracic region. An abdominal CT doesn't mean a CT done on the abdomen (not PRLOC), it is a CT scan that creates images of the abdominal region. |
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| title | cv.xpt |
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| Name | PR |
...
Row
...
STUDYID
...
DOMAIN
...
USUBJID
...
PRTRT
...
VISIT
...
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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| title | cv. | xpt|||||||||||||
| Name | TU | |||||||||||||
| Rowcaps | ||||||||||||||
| 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). | |||||||||||||
| Dataset2 | 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). | |||||||||||||
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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 |
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.
| Rowcaps | | |||||||||||||
| Row 1: | An aneurysm is present in the left renal artery. | |||||||||||||
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| Row 2: | An aneurysm is present in the Infrarenal Aorta | |||||||||||||
| Dataset2 | ||||||||||||||
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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