The below concept map shows the impact of creating a separate non-tumor lesion domain (which uses the original tumor domain structure) and how it affects modeling:
Example 1: Mapping the entire cardiovascular abnormality identification process in CV.
Two aneurysms are identified in the thoracic and abdominal regions.
CVLNKGRP provides the unique identifier for each identified aneurysm
cv.xpt
ROW | STUDYID | DOMAIN | USUBJID | CVSEQ | CVGRPID | CVLNKGRP | CVLNKID | CVTESTCD | CVTEST | CVLOC | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVRESLOC | CVRLODTL | CVMETHOD | VISITNUM | VISIT | CVDTC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ABC | CV | ABC-123 | 1 | ABNIND | Abnormality Indicator | Thoracic Region | Y | Y | Y | CT SCAN | 1 | BASELINE | 2020-04-27 | |||||||
| 2 | ABC | CV | ABC-123 | 2 | Target | A1 | Aneurysm 1 | ABNEXAM | Examination for Abnormality | Thoracic Region | Aneurysm | Aneurysm | Aneurysm | Thoracic Aorta | Aortic Arch to Descending aorta | CT SCAN | 1 | BASELINE | 2020-04-27 | ||
| 3 | ABC | CV | ABC-123 | 3 | ABNIND | Abnormality Indicator | Abdominal region | Y | Y | Y | CT SCAN | 1 | BASELINE | 2020-04-27 | |||||||
| 4 | ABC | CV | ABC-123 | 4 | Non-Target | Aneurysm 2 | ABNEXAM | Examination for Abnormality | Abdominal region | Aneurysm | Aneurysm | Aneurysm | Infrarenal aorta | proximal to the iliac bifurcation | CT SCAN | 1 | BASELINE | 2020-04-27 | |||
| 5 | ABC | CV | ABC-123 | 5 | Target | A1 | Aneurysm 1 | ABNROID | Abnormality (Role) Identification | Target for study intervention | Target for study intervention | Target for study intervention | CT SCAN | 1 | BASELINE | 2020-04-27 | |||||
| 6 | ABC | CV | ABC-123 | 6 | Non-Target | Aneurysm 2 | ABNROID | Abnormality (Role) Identification | Non-target for study intervention, monitor progression | Non-target for study intervention, monitor progression | Non-target for study intervention, monitor progression | CT SCAN | 1 | BASELINE | 2020-04-27 | ||||||
| 7 | ABC | CV | ABC-123 | 7 | Target | A1 | Aneurysm 1 | LENGTH | Length | 4 | cm | 4 | 4 | cm | CT SCAN | 1 | BASELINE | 2020-04-27 | |||
| 8 | ABC | CV | ABC-123 | 8 | Target | A1 | Aneurysm 1 | MAXLDIA | Maximal Luminal Diameter | 5 | cm | 5 | 5 | cm | CT SCAN | 1 | BASELINE | 2020-04-27 | |||
| 9 | ABC | CV | ABC-123 | 9 | Non-Target | Aneurysm 2 | LENGTH | Length | 2 | cm | 2 | 2 | cm | CT SCAN | 1 | BASELINE | 2020-04-27 | ||||
| 10 | ABC | CV | ABC-123 | 10 | Non-Target | Aneurysm 2 | MAXLDIA | Maximal Luminal Diameter | 2.5 | cm | 2.5 | 2.5 | cm | CT SCAN | 1 | BASELINE | 2020-04-27 |
Example 1: Observed abnormality that's also 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 even though it can be considered as a lesion, it should still be represented in CV. This includes its initial identification as well as all measurements of this aneurysm.
Example 2: Observed abnormality that's also a lesion and "target" for study intervention
The subject had a chest CT scan.
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.
Shows the TU representation of the target lesions:
Show the diameter measurements of the target lesion in TR at two visits:
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?
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.
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 this really the location where a intervention is "made"?
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