The transthoracic electrocardiography (TTE) produced images of the heart.
Valvular regurgitation technically is not considered as a lesion, can this be mapped to TU? – This is considered as a site of disease so it is in scope?
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).
Rows 1-2:
I examined the TTE image of the heart (test location) and found calcified mitral valve annulus (result location).
Rows 3-4:
I examined the TTE image of the heart (test location) and found that the mitral valve (result location) had become stenotic.
Rows 5-6:
I examined the TTE image of the heart (test location) and regurgitation of blood in the mitral valve back into the left atrium.
Note these tests were originally created as a CVTESTs, if users are using SDTMIG version 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
REGUR 1
VSC-Cardiac Valvular Stenosis Severity
VALVE STENOSIS CLASSIFICATION 2009 VERSION
Moderate
1
BASELINE
2020-04-27
2
ABC
RS(CC)
ABC-456
2
STEN 1
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.
Jordan: i originally mapped this to CV but this is an assessment of lesion severity, thusly can be considered as lesion properties? So I changed this dataset to TR instead. I seriously wonder whose idea it was to create a separate non-tumor lesion domain when everything on this page could have been mapped to the single CV domain (except the peer-reviewed, published clinical classifications). How do you expect users to know these details by just reading the SDTMIG?