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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:

...

Then, the result for each of these tests is 'POSITIVE' or 'NEGATIVE', affirming presence or identity of the specific pattern in question.  "

Our recommendationRecommendations and Rationales:

For modeling Open-ended Findings Question vs. Prespecified Findings Question, analogy can be drawn from the MB domain modeling principles. For modeling pre-specified finding findings vs open-ended findings 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 result of an open-ended question becomes the test or a test test or a test qualifier for the pre-specified findings questionfindings question. This modeling principle applies consistently in IS as well.

Therefore for the pre-specified ANA Stain Pattern tests,

...

Open-ended findings modeling: What ANA stain pattern antinuclear antibody staining pattern(s) do you observe in the specimen? (This is the IS Example 10 in the SDTMIG v3.4)

Con: This approach would only allow people to report the positive findings - ANA patterns that have been observed and reported as results. Patterns that are not observed will not be reported.

Supporting LOINC codes:

1. https://loinc.org/14722-3/ Presence
2. https://loinc.org/29953-7/ Titer
3. https://loinc.org/14611-8/ Pattern

...

Pre-specified findings modeling: Do you observe nuclear centromere /ANA pattern? Do you observe cytoplasmic speckled ANA pattern? etc.

Pro:

1. This approach allows the users to report both the "specific, pre-specified" positive and negative patterns, if interested. 
2. This is also almost a 1:1 mapping to LOINC codes.

Supporting LOINC Codes:

• https://loinc.org/53994-0/ Presence
• https://loinc.org/96921-2/ Titer

Decision Decisions and Additional Notes/Action Items: StatuscolourGreentitleApproved

• 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 Library.
• Status:

  Status
  colour Green title Approved