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:
Anti-Nuclear Antibody Centromere Pattern, Char |
Anti-Nuclear Antibody Centrosome Pattern, Char |
Anti-Nuclear Antibody Cytoplasmic Pattern, Char |
Then, the result for each of these tests is 'POSITIVE' or 'NEGATIVE', affirming presence or identity of the specific pattern in question.
Our recommendation:
For modeling pre-specified finding in MB, the approach has been:
- When asking an open-ended “what bug do you have in the culture” question, MBTEST = Microbial Organism Identification; MBORRES = Name of the Microorg (from the Microorg codelist).
- When asking for a pre-specified finding “do you have this particular named bug in the culture” type question, MBTEST = Name of the specific Microorg, MBORRES = positive/negative, present/absent.
The MB example is to illustrate that the result of an open-ended question becomes the test or a test qualifier for the pre-specified findings question. This modeling principle applies consistently in IS as well.
Therefore for the pre-specified ANA Stain Pattern tests,
- ISTEST = Autoantibody; ISBDAGNT = Nuclear Autoantigens; ISTSTDTL = Centromere Pattern/ Cytoplasmic Pattern/or other specific ANA Patterns; ISOORES = Positive/Negative. In this case, the ANA pattern results are mapped to ISTSTDTL, because they are “pre-specified” findings, and you are asking the question “do you observe this ANA pattern?”
- The IS example 10 in the SDTMIG 3.4 where ISTSTDTL = Staining Pattern, essentially serves to asks the “open-ended” question of “what ANA pattern do you observe?” - the specific ANA patterns are then treated as results.
- Additionally, having the values of “Staining Pattern”, “Centromere Pattern/ Cytoplasmic Pattern/or other ANA Patterns” mapped to IS Test Detail, is also the consistent use of this variable.
Open-ended findings modeling: What ANA stain pattern do you observe? (This is the IS Example 10 in the SDTMIG v3.4)
Con: This approach would only allow people to report the positive findings.
LOINC codes:
- https://loinc.org/14722-3/ Presence
- https://loinc.org/29953-7/ Titer
- https://loinc.org/14611-8/ Pattern
Pre-specified findings modeling: Do you observe nuclear centromere/cytoplasmic speckled ANA pattern?
Pro:
- This approach allows the users to report both the specific positive and negative patterns, if interested.
- This is also almost a 1:1 mapping to LOINC codes.
LOINC Codes:
- https://loinc.org/53994-0/ Presence
- https://loinc.org/96921-2/ Titer