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[BUG] Odm-export: ambiguous item values #314

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rhe-reliatec opened this issue May 5, 2022 · 3 comments
Open

[BUG] Odm-export: ambiguous item values #314

rhe-reliatec opened this issue May 5, 2022 · 3 comments
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@rhe-reliatec
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Description:
I found in an odm-export a line like this:

<ItemData IsNull="Yes" ItemOID="I_22KON_SPIRO_FEF2575" OpenClinica:ReasonForNull="NI" Value="&#228;&#196;6K&#246;rXmKtwQa7S-QSNbBiKUlwgVl681GynlM&#220;3oJBCl&#220;&#246;TvKMTTSTXR&#220;67&#214;G&#246;&#196;B4lo,NI,EI&#196;09TSYTXdh7U2Qg,Rlz&#220;Z?uEsI5liohZ&#252;&#228;Ez&#246;WAI7&#246;Xk4&#246;fI2E9nrA&#252;0?l1G4bQ-TTq?&#220;FJs&#196;vfmqRQCXsEdJURmNvl,&#246;btLKr&#220;7g&#246;EcSui,uMl2KCOxb&#220;RFHTOa&#246;i9dXivY4AnEVzJ-XvyviV5IO">

This says, that the item has no value - it is NULL, the user entered NI in the field and it also says the item has a value - the user entered some text.
This is confusing and wrong. Indeed the last state of the field is: it has some value, hence isNull="Yes" is wrong.

Requirements:
You can get such ItemData-nodes with LibreClinica 1.0 and with LibreClinica 1.1. I have win10, tomcat9, openjdk 8, postgres13.

The FormDef-nodes in the exported odm-xml show that NullValues is set to NI - what is also shown in the 'Update Study Event Definition'- dialog.
In other words the special treatment of null-values-feature is switched on for the crf.

</OpenClinica:FormDetails>
.
Many lines
.
.
<OpenClinica:PresentInEventDefinition PasswordRequired="No" DoubleDataEntry="No" ParticipantForm="No"
IsDefaultVersion="Yes" NullValues="NI," HideCRF="No" AllowAnonymousSubmission="No"
Offline="No" SourceDataVerification="not_required" StudyEventOID="SE_T0BASELINE"></OpenClinica:PresentInEventDefinition>
</OpenClinica:FormDetails>

Look at the attribute NullValues. Why a comma?

Steps to follow:

  1. Prepare a crf with null-values-feature switched on.
  2. Enter in a field NI
  3. Create a dataset with all items and export as odm: choose CDISC ODM XML 1.3 Full with OpenClinica extensions
  4. Search your item in the xml and you should find a line like:
    <ItemData ItemOID="I_20STU_SPIRO_FEF2575" IsNull="Yes" OpenClinica:ReasonForNull="NI"/>
  5. Enter in the same field a text which contains ,NI, eg bcd,NI,qwertz. Save. Export.
  6. Search your item in the xml and you will find a line like:
    <ItemData ItemOID="I_20STU_SPIRO_FEF2575" IsNull="Yes" OpenClinica:ReasonForNull="NI" Value="bcd,NI,qwertz">

Expected result:
I would expect ItemData-nodes without the attributes "IsNull" and "OpenClinica:ReasonForNull" for items with a real value.

Actual result:
ItemData-nodes which are marked as NULL-Value which have a value.

Similar effects:
Enter: NI,
You get: <ItemData ItemOID="I_20STU_SPIRO_FEF2575" IsNull="Yes" OpenClinica:ReasonForNull="NI,"/>
Enter: NI, CANNELLONI
You get: <ItemData ItemOID="I_20STU_SPIRO_FEF2575" IsNull="Yes" OpenClinica:ReasonForNull="NI" Value="NI, CANNELLONI">

I don't think it's such a good idea to use "magic strings".

@rhe-reliatec rhe-reliatec added the bug Something isn't working label May 5, 2022
@toskrip
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toskrip commented May 5, 2022

This null-values-feature for eCRF is unsupported. For as long as I can remember the official original documentation was stating to not to use it because it is deprecated and may be removed from any future release. It was recommended to rather define your null value codes as response option text and response value in specific eCRF template.

@rhe-reliatec
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A Customer used it. Maybe it is a good idea to remove this.

@toskrip
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toskrip commented May 5, 2022

I agree. At least from GUI it should be possible to remove this completely so that nobody tries to use it.

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