The Tumor/Lesion domains (TU, TR) represent data collected in clinical trials where sites of disease (e.g., tumors/lesions/locations of interest, lymph nodes, organs of interest in the assessment of the disease) are identified and then repeatedly measured/assessed at subsequent time points and often used in an evaluation of disease response(s).
The below example shows the identification of calcification in the mitral valve annulus as well as mitral valve stenosis. It also shows mitral valve regurgitation. Technically, regurgitation is not considered as a lesion, however it is the direct result of the lesion (mitral valve stenosis/narrowing and structural change, caused by the annular calcification). Should this be mapped to TU as well? I suppose you could consider this as a site of disease, specifically locations of interest where you identify then repeatedly assess?
Agreed modeling approach allows us to represent the variety of lesions and abnormal findings associated with said lesions into TUORRES.
Rows 1-3:
Examination of the heart indicates calcified mitral valve annulus and mitral valve stenosis.
Rows 4-5:
Examination of the heart indicates regurgitation at the mitral valve, blood is regurgitating from the left ventricle into the left atrium.
The following example shows how to model severity assessments of the identified lesions and abnormalities based on peer-reviewed, validated and published instruments (either copyrighted or public domain). Note these tests were originally created as a CVTESTs, if users are using SDTMIG versions prior to 3.4. Per SDTMIG 3.4, this is now considered as a grading scale and therefore should now be represented as CC/RS.
Row 1:
Mitral valve stenosis is moderate.
Row 2:
Mitral valve regurgitation is severe.
$titleHtml
rs.xpt
Row
STUDYID
DOMAIN
USUBJID
RSSEQ
RSLNKID
RSTEST
RSCAT
RSORRES
VISITNUM
VISIT
RSDTC
1
ABC
RS(CC)
ABC-456
1
mv stenosis
VSC-Cardiac Valvular Stenosis Severity
VALVE STENOSIS CLASSIFICATION 2009 VERSION
Moderate
1
BASELINE
2020-04-27
2
ABC
RS(CC)
ABC-456
2
mv regurgitation
SNVRC-Cardiac Valvular Regurgitation Severity
SEVERITY OF NATIVE VALVULAR REGURGITATION CLASSIFICATION 2003
Severe
1
BASELINE
2020-04-27
Dataset Debug Messages
There seem to be multiple domains (RS(CC)) present in the dataset.
The below example shows how to represent calcification severity from a sponsor defined criteria using the TR domain. The Mitral Valve Annulus identified in TU is severely calcified.