TU, TR and RS Concept map
Case 1 - Subject has both TAA and AAA
The subject had a chest CT scan and an abdominal CT scan.
Are chest and abdomen really locations of the procedure?
Questions and Thoughts
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 create ultrasonic views 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):
- Transducer is inserted into 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 recently took a family member 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 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.
- 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 abnormal structure of the location - i.e. in the RIGHT POSTERIOR DESCENDING ARTERY (PRLOC), the angioplasty breaks up the blockage and inserts a stent.
- Brachytherapy places radioactive material inside a location of the body to kill cancer cells, e.g. prostate. The procedure occurs, intervenes and alters the abnormal structure of the location.
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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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.
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.
Case 2 - Subject has AAA but TAA is not found
The subject had a MRI that scanned his torso, from chest to abdomen.
Questions and Thoughts
Again, is there a PRLOC for the MRI procedure? You are scanning the subject from the chest to the abdomen.
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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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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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: 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 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 it. I think it is not wrong to populate TULOC with chest and abdomen as well, they are just not the most precise anatomical terms.