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Update Lab Grading Criteria Metadata #2492

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kaz462 opened this issue Aug 7, 2024 · 4 comments · Fixed by #2555
Closed

Update Lab Grading Criteria Metadata #2492

kaz462 opened this issue Aug 7, 2024 · 4 comments · Fixed by #2555
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@millerg23

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@kaz462
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kaz462 commented Aug 7, 2024

Grading Criteria Metadata NCI-CTCAEv5

  1. From lab_grading/assumptions-made-when-grading:

    For BASE to be abnormal we compare it with the Upper Limit of Normal (ULN) ANRHI, i.e. BASE > ANRHI

    • I encountered a situation where ANRHI differs within a subject and lab test due to data from different lab vendors. Should we consider changing the use of ANRHI to BNRIND when determining whether the baseline is normal/abnormal?

  2. Some CTCAE grade definitions contain two sets of units, but only one is provided in the current grading metadata. For example, TERM=Hypoalbuminemia has only one row for unit = g/L, so it's not be able to grade for unit = g/dL
    image
    can we add more rows to the metadata to cover different units?

Originally posted by @kaz462 in #2191 (comment)
@bms63
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bms63 commented Sep 18, 2024

Hey @millerg23 just checking on the progress for this issue

@millerg23 millerg23 linked a pull request Nov 7, 2024 that will close this issue
Closes #2492 use ANRIND for abnormal baseline #2555
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@millerg23
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@bms63 you OK if we spit this into 2 separate issues? One for using BNRIND (I just created a pull request for this), and another issue for handling different units?

@bms63
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bms63 commented Nov 7, 2024

I always love breaking things into smaller things and finishing them quickly! What ever makes sense here for you I am okay with!

@bundfussr bundfussr moved this from Backlog to In Progress in admiral (sdtm/adam, dev, ci, template, core) Nov 7, 2024
@millerg23
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Created #2557 to cover different units.

bms63 added a commit that referenced this issue Nov 25, 2024
@millerg23 @bms63
Closes #2492 use ANRIND for abnormal baseline (#2555)
01420bd 
* 2492 use ANRIND for abnormal baseline

* 2492 abnormal_indicator added to metadata and function

* 2492 fix LINTR

* 2492 make final updates including Vignette

* Update NEWS.md

---------

Co-authored-by: Ben Straub <[email protected]>
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Closes #2492 use ANRIND for abnormal baseline pharmaverse/admiral
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@bms63 @kaz462 @millerg23