QSMETHOD : Variable not recommended for use

p Pierre

on January 15, 2016

Hi,

I ran the latest version of Pinnacle 21 and got the following warning : QSMETHOD Variable not recommended for use (SD1075 or FDAC030) in QS domain.

According to the EQ-5D-5L Questionnaire SDTM Guideline V1.1, the variable QSMETHOD should be used to indicate that the VAS Score was collected using the Visual Analog Scale (0-100).

I think there should thus be an update for this check.

Thanks

Pierre

Forums: SDTM

s Sergiy

on January 18, 2016

Hi Pierre, SDTM IG 3.1.x

Hi Pierre,

SDTM IG 3.1.x says (#6.3.5.1 on page 147) that "4. The following Qualifiers would not generally be used in QS: ..., --METHOD, ....". Based on this text the Validator considers QSMETHOD as "Not Recommended" variable.

In IG version 3.2 QSMETHOD variable was removed from the list and its new P21 Core attribute should be "Model Permissible". However, it is still unchanged in SDTM IG 3.2 specifications of P21 Validator. This bug will be fixed in the next release.

I am not sure how to handle specifications for older versions of SDTM. Most likely we will also use a "Model Permissible" attribute value as a correction of obvious error/inconsistency in early versions of SDTM standard.

Thank you for reporting this issue!

Kind Regards,

Sergiy