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The original LOINC-SDTM-LB mapping as published by CDISC in 2020, contained a number of "Supplemental Qualifier" (or "non-standard" - NSV) variables, which have been added as CDISC finally realized that the existing set of variables is not capable to uniquely define a lab test.
When then the SDTM 2.0 model and SDTMIG-3.4 Implementation Guide were published, these "non-standard variables" were added, but unfortunately, not always with the same variable name
as in the LOINC-SDTM-LB mapping of 2020!
Whereas mappers using earlier versions of the SDTMIG (3.3 and earlier) can directly use the results of the RESTful Web Service in their work,
the name returned by the RESTful Web Service corresponding 1:1 to what is usual in SDTM, including the NSVs, this is not the case anymore
for SDTMIG-3.4.
For example, for LOINC code 34183-4, the RESTful Web Service returns:
with the NSV being: SUPPLB.LBPTFL (Point in Time Flag), SUPPLB.LBPDUR (Planned Duration), SUPPLB.LBRESTYP (Result Type), SUPPLB.RSLSCL (Result Scale),
SUPPLB.LBTSTOPO (Test Operational Objective), SUPPLB.LBLLOD (Lower Level of Detection), SUPPLB.LBTSTCND (Test Condition), and SUPPLB.LBMTHSEN (Method Sensitivity).
Remark that the NSV variable labels (in brackets) are only indicative, as for NSVs, the user is always free to choose a suitable name him/her-self.
SDTM 2.0 / SDTMIG-3.4 mostly follows these names and labels, however makes them core variables (so, not NSVs anymore), but with some slight differences in names and labels.
This also means that one cannot just take the second part (after "SUPPLB.") for the variable name when using SDTMIG-3.4.
Therefore we here provide a list of these variables, first providing the name as returned by the RESTful Web Service, then the SDTM 2.0 / SDTMIG-4.3 new name, and in the third column the new SDTM 2.0 / SDTMIG-4.3 new label. This can then be used for getting everything right when using the RESTful Web Service in combination with SDTMIG-3.4.
| Var. Name returned by the RESTful-WS | SDTM 2.0 / SDTMIG-3.4 Variable Name | SDTM 2.0 / SDTMIG-3.4 Variable Label | Remarks |
|---|---|---|---|
| SUPPLB.LBPTFL | LBPTFL | Point in Time Flag | |
| SUPPLB.LBPDUR | LBPDUR | Planned Duration | |
| SUPPLB.LBRESTYP | LBRESTYP | Result Type | |
| SUPPLB.LBRSLSCL | LBRESSCL/LBRSLSCL | Result Scale | The latest update (2022-07-21) of the IG speaks about both --RESSCL as --RSLSCL, whereas the model says --RESSCL. One of both must definitely be incorrect! There is a JIRA-ticket (https://jira.cdisc.org/browse/SDS-2407) stating that the SDTMIG should be updated, but no addendum with a correction/clarification has been published. Once again an argument for having model and IG in real electronic form (no, I don't mean Excel) BEFORE publication, so that consistency can be checked by software, and not by the human eye. |
| SUPPLB.LBTSTOPO | LBTSTOPO | Test Operational Objective | |
| SUPPLB.LBLLOD | LBLLOD | Lower Limit of Detection | |
| SUPPLB.LBTSTCND | LBTSTCND | Test Condition | |
| SUPPLB.LBMTHSEN | NOT MENTIONED! | As --MTHSEN is neither mentioned in SDTMIG-3.4 nor the SDTM-2.0 model one must still use it as an NSV, i.e. use SUPPLB.LBMTHSEN |
Courtesy of XML4Pharma - last update: July 2022