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A concept map that helps me to understand all the questions and the impact of a separate non-tumor lesion domain:
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Question 1: just because something is considered as a lesion, does that mean that it should be mapped to the lesion domains?
Two aneurysms are identified in the thoracic and abdominal regions, one is considered as "target" for study treatment and the other "non-target" for study treatment.
CVREFID provides the unique identifier for each identified aneurysm.
CVLNKID will link the CV records to other domain datasets, such as RS and CC for disease response to treatment and clinical classification data (data not shown).
CVGRPID is used to group data for target and non-target aneurysms.
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Case 1 - 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 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:
- 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 get 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):
- Done from the inside of 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 took my mother 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'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????
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| Name | PR |
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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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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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| Name | TU |
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STUDYID
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DOMAIN
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USUBJID
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TUGRPID
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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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ABC
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Target?
Identified
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Target?
Identified
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| Name | TR |
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The TU/TR/RS domains were created for tumors which in themselves don't belong in any body system domains (tumor can grow and spread to any place), hence they are in their own domains. At some point, non-tumor lesion was added to TU/TR. SDTM now has body-system domains, it then begs the question whether a separate non-tumor lesion domain is needed, when most "lesions" and things that could be considered as lesions, can go into their respective body-system domains. Can the body system domains offer the "unique lesion identifier" through the use of, GRPID, REFID, or other identifier variables?
Question 2: how do you map lesions that are non-target for study treatment?
TU/TR/RS were originally built to assess tumor response to "study" treatment. Both "target" and "non-target" tumors receive the same study treatment, are then tracked and evaluated. "Target" and "non-target" tumor properties are mapped to TR and their responses to treatment are mapped to RS. Depending on the criteria used, "Target" and "non-target" tumor responses to treatment are evaluated a little differently. "Non-target" in the tumor context, does NOT mean, "not treated by study intervention".
In the CV data element projects, non-target is used to describe a lesion that will NOT be treated by a study intervention. Such a lesion may be untreated, managed by a non-study drug, or treated with a non-study device or procedure. This type of data has also been mapped into TU and TR, is this correct? If TU/TR are built to house lesion response to study treatment type of data, then I think the CV modeling is incorrect, and if so, how do we deal with it?
Example 2: Observed abnormality that's a lesion, but "non-target" for study intervention, it is not treated and continuously monitored.
A small aneurysm is revealed by the abdomen CT scan. This aneurysm is small and is considered as "non-target" for study intervention, it is untreated and continuously monitored. Not sure whether this can be mapped to TU/TR, hence mapped to CV.
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STUDYID
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USUBJID
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TRTEST
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TRORRES
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TRLOC
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TRMETHOD
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VISITNUM
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VISIT
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TRDTC
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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 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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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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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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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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Example 3: Observed abnormality that's also a lesion and "target" for study intervention
The chest CT revealed a large aneurysm in the thoracic aorta which is "target" for study intervention. Note the use of the NSV TUFLAG to show that this abnormality is also considered as a target lesion for study intervention, tracking and/or disease response to treatment assessment. When the TUFLAG is marked with Y, measurements of the lesion should be represented in TU, TR and/or RS.
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STUDYID
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TUGRPID
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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?
Identified
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Dissection Location/Identification
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Target?
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CT SCAN
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Target?
Identified
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CT SCAN
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Shows the TU representation of the target lesions:
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STUDYID
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DOMAIN
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USUBJID
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TRLNKID
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TRTEST
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TRORRES
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TRLOC
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TRMETHOD
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VISITNUM
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VISIT
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CVDTC
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Dissection Location/Identification
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Target?
Identified
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CT SCAN
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Show the diameter measurements of the target lesion in TR at two visits:
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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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RSLNKID
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RSTEST
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RSORRES
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VISITNUM
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VISIT
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CVDTC
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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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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.
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"? |
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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