ADaM labels with placeholders - inclusion of ADSL TRTxxP and TRTxxA into BDS in 2.1.0

Pinnacle 21 Support ADaM
1

n 2.0.2 we did not include these variables in BDS. This is why you did not get the AD0018 label error when including ADSL.TRTSEQA into your BDS. Since 2.1.0 has the TRTxxA(N) and P(N) variables in BDS, there was a conflict with the TRTSEQA and TRTSEQP

Why did we include TRTxxA(N) and P(N) into BDS in v2.1.0 ?

  1. ADaM IG 1.0 TTE explicity includes them as time to event variables.
  2. ADaM IG 1.0 says “for BDS that TRTxxP (copied from ADSL) may also be needed for some analysis purposes, and may be useful for traceability and to provide context”
  3. ADaM IG 1.0 p20 says that any ADSL variable may be copied to BDS.

Most false positives deal with labels in data. And these issues are specific to
– sas technology .xpt, .sas7bdat
– ADaM placeholders fragments (xx, y, zz)

We as an industry should reconsider (but not eliminate) the effort of validating labels in data against labels in metadata to such an extent, especially when they are not used by automated analysis tools. They are their to serve manual human review.

Immediate, easy work-around

  1. open your components\config\ADaM 1.0.xml
  2. Seach for any variable that exists in ADSL, that you want in BDS (if not already there) as in: <ItemRef
    ItemOID=“IT.ADSL.TRTSEQP” OrderNumber=“35” Mandatory=“No” Role="Treatment"val:Core=“Conditional”/>
  3. Copy the line above and paste it as the last ItemRef in BDS. Optionally change the orderNumber, but it probably doesn’t matter. Rerun and watch your AD0018 go away !

Long term solution (for Pinnacle)

1.) explicity assign every ADSL variable in BDS - can be immediately done with metadata
2.) inspect ADSL variables when validating BDS variable metadata. Requires software change

Thanks for your patience and support

Mike.

Reference

ADSL variabled Copied to BDS
(explicity exists in BDS config as of 2.1.0)

ADSL variabled Copied to BDS
(does not exist in BDS config)

BDS

TRT__*__P

Planned Treatment for Period $1

BDS

TRTSEQP, Planned Sequence of Treatments

BDS

TRT__*__PN

Planned Treatment for Period $1 (N)

BDS

TRTSEQPN, Planned Sequence of Treatments (N)

BDS

TRT__*__A

Actual Treatment for Period $1

BDS

TRTSEQA, Actual Sequence of Treatments

BDS

TRT__*__AN

Actual Treatment for Period $1 (N)

BDS

TRTSEQAN, Actual Sequence of Treatments (N)