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Example 1: Observed abnormality that's also a lesion "target" for study intervention

The subject had a chest CT scan and an abdominal CT scan.

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pr.xpt

Row

STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

PRLOC

VISIT

 1  ABCPR  ABC-1231CT SCANCHESTBASELINE
2  ABCPR  ABC-1232CT SCANABDOMENBASELINE
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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 lesion for study intervention, tracking and/or disease response to treatment assessment.

cv.xpt

cv.xpt

ROW

STUDYID

DOMAIN

USUBJID

CVSEQ

CVLNKIDCVTESTCD

CVTEST

CVLOC

CVORRES

CVSTRESCCVSTRESNCVRESLOCCVRLODTL

CVMETHOD

VISITNUM

VISIT

CVDTC


TUFLAG
1ABCCVABC-1231TRABNINDAbnormality IndicatorThoracic regionYYY

CT SCAN

1BASELINE2020-04-27

2ABCCVABC-1232TR-AneurysmABNEXAMExamination for AbnormalityThoracic regionAneurysmAneurysmAneurysmThoracic AortaAortic Arch to Descending aorta

CT SCAN

1BASELINE2020-04-27

3ABCCVABC-1233TR-DissectionABNEXAMExamination for AbnormalityThoracic regionArterial DissectionArterial DissectionArterial DissectionDescending aorta

CT SCAN

1BASELINE2020-04-27

4ABCCVABC-1234TR-AneurysmTARGSINTTarget for Study Intervention
TargetTargetTarget

CT SCAN

1BASELINE2020-04-27
Y
5ABCCVABC-1235TR-DissectionTARGSINTTarget for Study Intervention
TargetTargetTarget

CT SCAN

1BASELINE2020-04-27
Y

Dataset Debug Message

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Shows the TU representation of the target lesions:

tu.xpt

tu.xpt

Row

STUDYID

DOMAIN

USUBJID

TUSEQTULNKIDTUTESTCD

TUTEST

TULOC

TULOCDTL

TUORRES

TUSTRESC

TUMETHOD

VISITNUM

VISIT

TUDTC

1ABCTUABC-1231TR-Aneurysm
Lesion (Role) IdentificationThoracic AortaAortic Arch to Descending aortaTargetTarget

CT SCAN

1BASELINE2020-04-27
2ABCTUABC-1232TR-Dissection
Lesion (Role) IdentificationDescending aorta
TargetTarget

CT SCAN

1BASELINE2020-04-27
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Shows the diameter measurements of the target lesion in TR:

tu.xpt

tr.xpt

Row

STUDYID

DOMAIN

USUBJID

TRSEQTRLNKIDTRTESTCD

TRTEST

TRORRES

TRORRESU

TRSTRESC

TRSTRESN

TRSTRESU

VISITNUM

VISIT

TUDTC

1ABCTUABC-1231TR-AneurysmLENGTHLength4cm44cmcmBASELINE2020-04-27
2ABCTUABC-1232TR-AneurysmMAXLDIAMaximal Luminal Diameter5cm55cmcmBASELINE2020-04-27
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Example 2: Observed abnormality that's also a lesion, but "non-target" for study intervention, it is managed by a non-study drug (e.g. beta blockers, hypertension drug).

cv.xpt

cv.xpt

ROW

STUDYID

DOMAIN

USUBJID

CVSEQCVLNKIDCVGRPIDCVTESTCD

CVTEST

CVLOC

CVORRES

CVORRESUCVSTRESCCVSTRESNCVSTRESUCVRESLOCCVRLODTL

CVMETHOD

VISITNUM

VISIT

CVDTC


TUFLAG
1ABCCVABC-1231
ARABNINDAbnormality IndicatorAbdominal regionY
YY


CT SCAN

1BASELINE2020-04-27

2ABCCVABC-1232
AR-AneurysmABNEXAMExamination for AbnormalityAbdominal regionAneurysm
AneurysmAneurysm
Infrarenal aortaproximal to the iliac bifurcation

CT SCAN

1BASELINE2020-04-27

3ABCCVABC-1235
AR-Aneurysm
Target for Study Intervention
non-target for study intervention
non-target for study interventionnon-target for study intervention



1BASELINE2020-04-27

4ABCCVABC-1233
AR-AneurysmLENGTHLength
2cm22cm

CT SCAN

1BASELINE2020-04-27

5ABCCVABC-1234
AR-AneurysmMAXLDIAMaximal Luminal Diameter
2.5cm2.52.5cm

CT SCAN

1BASELINE2020-04-27

Dataset Debug Message

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The dissected descending aorta (LNKID =Dissection 1) is classified based on the Stanford Aortic Dissection System as type B.

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.

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rs.xpt

Row

STUDYID

DOMAIN

USUBJID

RSSEQ

RSLNKID

RSTESTCD

RSTESTRSCAT

RSORRES

RSSTRESC

VISITNUM

VISIT

CVDTC

1ABCRS(CC)ABC-12311STAN0101STAN01-Stanford Aortic Dissection Classification TypeSTANFORD AOD CLASSIFICATIONSTANFORD BSTANFORD B1BASELINE2020-04-27

Dataset Debug Messages

  • There seem to be multiple domains (RS(CC)) present in the dataset.
  • Please remove all formatting (see How to Clear Formatting).

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:

  1. 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.
  2. Creates images of the entire coronary artery system.
  3. We don't record PRLOC = chest for this procedure

Thransthoracic Echocardiogram (TTE):

  1. 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.
  2. Creates images of the heart.
  3. We don't record PRLOC = Chest and upper abdomen for this procedure

Transesophageal Echocardiogram (TEE):

  1. Transducer is inserted into the Esophagus.
  2. Creates images of the heart.
  3. We don't record PRLOC = Esophagus

Cine Angiography:

  1. Done on the chest, again the probe is placed on top of the chest.
  2. Creates images of the entire coronary artery system.

In addition, i just recently took a family member to have a Thyroid Ultrasound:

  1. The ultrasound probe moved around her neck
  2. 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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