Documentation: Lab Grading vignette

[millerg23]

Please select a category the issue is focused on?

Lab grading Vignette reviewed by Lab group in Roche

Let us know where something needs a refresh or put your idea here!

Users at Roche reported the following typos:

1. Under "NCI-CTCAEV5 implementation" section in "Terms graded"
   From the SOC = “Metabolism and nutrition disorders” there are 12 CTCAE v4.0 Terms:
   Should be
   From the SOC = “Metabolism and nutrition disorders” there are 12 CTCAE v5.0 Terms:
   Likewise,
   From the SOC = “Blood and lymphatic system disorders” there are 2 CTCAE v4.0 Terms:
   Should be
   From the SOC = “Blood and lymphatic system disorders” there are 2 CTCAE v5.0 Terms:

2. Under "NCI-CTCAEV5 implementation" section in "Assumptions made when grading"
   For “Hyponatremia”, where Grade 2 and Grade 2 criteria is the same with respect to the lab value, then worse case is assumed as grade 3.
   Should be
   For “Hyponatremia”, where Grade 2 and Grade 3 criteria is the same with respect to the lab value, then worse case is assumed as Grade 3.

3. Under "NCI-CTCAEV5 implementation" section in "Assumptions made when grading"
   Similarly, for terms “Lipase Increased” and “Serum amylase increased” there is the following criteria:
   The table under this correctly displays “Lipase Increased” and “Serum amylase increased”, however in the very next table under
   admiral assumed worst case and implemented highest grade possible. The decision made was put in the COMMENT field.
   The table displays "INR increased" instead of “Lipase Increased”

4. Under "NCI-CTCAEV5 implementation" section in "Terms graded"
   Note: These are the same terms identified for NCI-CTCAEv4, except “Hypophosphatemia” and “Hyperglycemia” which are not in NCICTCAEv5 grading criteria.
   Should be changed to:
   Note: These are the same terms identified for NCI-CTCAEv4, except “Hypophosphatemia” and “Hyperglycemia” which are not gradable by quantitative lab values in NCICTCAEv5 grading criteria.

5. Under "NCI-CTCAEV5 implementation" section in "Assumptions made when grading"
   I wonder whether this Section could actually be updated/ clarified in terms of overall format and content, as I find it confusing
   Maybe we could add the following 2 sub-sections:

• "Criteria dependent on the Baseline Value"
• "Worst case scenario and implementation of highest grade possible"
  I feel that we could have all the labs from the v5 medata with a "Comment" highlighted as part of a table in this Section, so that it would be clear which labs are impacted.

6. Could a download be available on Vignette of the metdata, for reviewers to look at easily, currently the package must be loaded to view the metadata datasets in R. (Note: we are looking to store JSON files to hold metdata instead of the xlsx files we currently have).

[millerg23]

@bms63 maybe we could have a quick lab meeting about this after this release, see if Zelos is available??
Points 5 and 6 above may need some discussion. Points 1 to 4 are straightforward updates.

[bms63]

Yeah that sounds good! @zdz2101 you have any availability in the coming future?