Page History
Request | Notes | Status | Fixed/Updated/Removed from SDTMIG v4.0? | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
This is sponsor inquiry. How do you model pre-specified ANA tests? | Question about how to model ANA data that are collected, and therefore should be molded differently from the example that's shown in the SDTMIG 3.4. |
|
2023-03-24: Added to SDTMIG v4.0. |
User Inquiry:
"I wanted to revisit this discussion on ANA pattern reporting. We also deal with testing labs where they pre-coordinate the pattern result into the test name and perform a call of whether the pattern is observed or not. For example, the 'test' the lab performs evaluates each staining pattern as listed below:
...
The MB example is to illustrate that the result of an open-ended findings question becomes the test or a test qualifier for the pre-specified findings question. This modeling principle applies consistently in IS as well.
...
- This approach allows the users to report both the "specific, pre-specified" positive and negative patterns.
- This is also almost a 1:1 mapping to LOINC codes.
- Consistent modeling approach across specimen-based domains.
Supporting LOINC Codes:
- https://loinc.org/53994-0/ Presence
https://loinc.org/96921-2/ Titer
Example title IS Example 2 Dataset wrap Name IS Dataset2 Row
STUDYID
DOMAIN
USUBJID
ISSEQ
ISREFID
ISGRPID
ISTESTCD
ISTEST
ISBDAGNT
ISTSTDTL
ISTSTOPO
ISORRES
ISORRESU
ISSTRESC
ISSTRESN
ISSTRESU
ISSPEC
ISMETHOD
VISITNUM
VISIT
ISDTC
1 XYZ IS XYZ1234 1 19283746 1 ATAB Autoantibody NUCLEAR AUTOANTIGENS CYTOPLASMIC, SPECKLED PATTERN SCREEN POSITIVE POSITIVE SERUM FLUORESCENT IMMUNOASSAY 1 SCREENING 2018-06-20 2 XYZ IS XYZ1234 2 19283746 1 ATAB Autoantibody NUCLEAR AUTOANTIGENS CYTOPLASMIC, SPECKLED PATTERN QUANTIFY 1:170 170 170 titer SERUM FLUORESCENT IMMUNOASSAY 1 SCREENING 2018-06-20 3 XYZ IS XYZ1234 1 19283746 2 ATAB Autoantibody NUCLEAR AUTOANTIGENS NUCLEAR, NUCLEOLAR PATTERN
SCREEN POSITIVE POSITIVE SERUM FLUORESCENT IMMUNOASSAY 1 SCREENING 2018-06-20 4 XYZ IS XYZ1234 2 19283746 2 ATAB Autoantibody NUCLEAR AUTOANTIGENS NUCLEAR, NUCLEOLAR PATTERN
QUANTIFY 1:340 340 340 titer SERUM FLUORESCENT IMMUNOASSAY 1 SCREENING 2018-06-20 5 XYZ IS XYZ1234 1 19283746 ATAB Autoantibody NUCLEAR AUTOANTIGENS NUCLEAR, CENTROMERE PATTERN
SCREEN NEGATIVE NEGATIVE SERUM FLUORESCENT IMMUNOASSAY 1 SCREENING 2018-06-20
...
- Team is happy with both approaches, this "reciprocal" modeling approach provides flexibility and allows sponsors to accommodate different data collection schemas. It is also highly consistent with LOINC, both example have LOINC codes corroboration.
- Jordan to enter this into the CDISC Example Libraryalready added this one to the SDTMIG v4.0.
Resolution Status: | Date | ||||||
---|---|---|---|---|---|---|---|
|
|
...