Value level metadata for user defined --TESTCD

Lex

on June 2, 2020

Code/Decode display

The way the style sheet works is that it utilizes the codelist associated with the LBTESTCD variable. When this codelist has both coded values and decoded values, it displays the decoded values between parentheses to help reviewers understand what the coded value means. For example, ALB stands for Albumin Measurement.
This is useful information for reviewers.
My guess is that you added PUS as a LBTESTCD value in the value level metadata, but you did not add the term for PUS (and the decoded value) in the codelists associated with LBTESTCD and LBTEST.
Adding the term should fix the issue.

Lex Jansen
PhUSE Define-XML 2.0 Stylesheet Recommendations team

Sergiy

on June 2, 2020

P21

Codelist for LBTESTCD does not include PUS or Decoded value

Hi Neeta, 

When open your define.xml file in browser like Internet Explorer, machine-readable structure is converted into human-readable format by a special stylesheet file (e.g., “define2-0-0.xsl”). This stylesheet file includes programmable instructions on how to show content of your define.xml file. Using different stylesheets, you will see different representations of your define.xml file in browser. For example, a stylesheet controls a look of WhereClauses in VLM.

If variable utilized in WhereClause has a Codelist with Decoded attribute for Codelist items, then a stylesheet uses Decoded values as description of the condition.

In your case, your define.xml file has LBTESTCD variable which has a Codelist with Decoded values for items like “ALB=Albumin Measurement”. Most likely, a Codelist for LBTESTCD does not include a term “PUS” or this term does not have Decoded value. That may be a reason why you cannot see a description of condition LBTESTCD EQ PUS.

Kind Regards,
Sergiy  

Code/Decode display

Hi Neeta,

How did you create your codelist entry for "PUS"? Did you use a tool with a graphical user interface that allows you to choose whether to add it with a "decode" or without it?

If you look into the real code of your define.xml (e.g. using NotePad++), I guess you have something like:

<EnumeratedItem CodedValue="PUS" def:ExtendedValue="Yes"/>

Whereas what you probably want is:

<CodeListItem CodedValue="PUS" def:ExtendedValue="Yes">
<Decode>
<TranslatedText xml:lang="en">........</TranslatedText>
</Decode>
</CodeListItem>

Where  ..... is where the real name of the analyt comes. OR ... the "Decode" part is completely missing which should give you a validation error.

Please also note that mixing "EnumeratedItem" with "CodeListItem" within the same CodeList is not allowed.

As Lex said, the stylesheet picks up the text value of "TranslatedText" (where I have put the ".....") and displays it in brackets.

For developing and generating define.xml files, use of a GUI based tool is always a good idea. These usually also have validation engine in it, and also a possibility to inspect the underlying source XML. In the CDISC Define-XML trainings, we also learn the attendees to at least understand the underlying XML. Not bad either...

Thank you all for your…

Thank you all for your inputs. I understand it better now how these values are getting populated. For standard codelist testcodes, I had added NCI Preferred Term as Decoded Value so it got populated automatically. I had kept Decoded Value column blank for user-defined testcodes so it was presented as blank parentheses. 

As a fix, I've populated Decoded Value column in specs for user-defined codes and it fixed the issue.

Sergiy

on June 3, 2020

P21

Use corresponding --TEST value as Decoded for --TESTCD term

Hi Neeta,

The common practice is to use corresponding --TEST value as Decoded Value for --TESTCD term. It helps to better understand relationships in your study data. For example, I prefer to see "ALB - Albumin" instead of "ALB - Albumin Measurement" 

Such approach is also more simple in terms of automation and avoids potential problems like you have with non-standard term "PUS".

Similar QNAM/QLABEL, VISITNUM/VISIT, ARMCD/ARM, ETCD/ELEMENT, --TPTNUM/-TPT, PARAMCD/PARAM, SEXN/SEX, etc.

Kind Regards,
Sergiy