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© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
1 Introduction
This document describes the CDISC implementation of the Psoriasis Area and Severity Index Version 2 Feldman (PASI V2FELDMAN) instrument. Note that Version 1 of the CDISC Controlled Terminology is scheduled for deprecation and an associated CDISC Version 1 instrument and SDTMIG QRS supplement were never released.
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CDISC would appreciate supplement reviewers' input on their experience in using the PASI V2 FEDLMAN instrument regarding what responses are being used for symptoms "erythema/redness", "thickness/induration" and "desquamation/scaling". There are 3 possible references that were found to explain PASI:
CDISC would appreciate reviewer help regarding which list of responses are used (those that mirror Feldman, Fredriksson, EMA, or some other combination). If the responses list is not in a majority (per public comment), it will be considered “undetermined.” The supplement will allow a sponsor’s list of responses, as was done in the CDISC PGI and CGI supplements. |
1.1 Representations and Warranties, Limitations of Liability, and Disclaimers
This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.
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Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.
2 Copyright Status
CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the PASI V2in the CDISC library of QRS data standards supplements. Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the instrument. There may be many versions of this instrument. CDISC has chosen to use this version as the data standard.
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Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005;64(Suppl 2):ii65–ii68.
3 The RS Domain Model
3.1 Assumptions for the RS Domain Model
All assumptions and business rules described in the SDTMIG RS domain are applicable to this supplement. Additional assumptions specific to the PASI V2 are listed below.
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The scale points for the symptoms include a numeric rating (0-4) and a definition of what is represented by the rating (e.g., 0 = "None"). For the PASI V2, RSORRES is populated with the text description; the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.
- CDISC created a CRF based on the Feldman article using the symptom terms "erythema/redness", "thickness/induration", and "desquamation/scaling". Per subject-matter expert recommendations, desquamation was included with scaling even though desquamation is not referenced in the Feldman article.
- CDISC created a CRF based on the Feldman article using the symptom terms "erythema/redness", "thickness/induration", and "desquamation/scaling". Per subject-matter expert recommendations, desquamation was included with scaling even though desquamation is not referenced in the Feldman article.
- The scale points for the area include a numeric rating (0-6) and a definition of what is represented by the rating (e.g., 0 = "0 (clear)"). For the area, RSORRES is populated with the text description; the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.
The PASI V2 instrument includes subscores and a total score that are considered as captured data on the CRF and are not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from the Feldman reference.
If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotals and total scores. An investigator-derived score will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (--DRVFL) is set to "Y". However, when the subtotal and total scores are received from a central provider or vendor, the value would go into --ORRES and --DRVFL would be null (see SDTMIG Section 4.1.8.1, Origin Metadata for Variables).
If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.
Records are created in rs.xpt for every item on the instrument:
For items with no data, RSORRES, RSSTRESC, and RSSTRESN are all missing and RSSTAT = "NOT DONE". If the reason is known, that reason is represented in RSREASND (e.g., RSREASND = "REFUSED"). If the reason is unknown, RSSTAT = "NOT DONE" and RSREASND is missing.
Terminology
RSCAT, RSTESTCD, and RSTEST values are included in CDISC Controlled Terminology.
A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.
3.2 Example for the PASI V2 RS Domain Model
The PASI V2 example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for 1 subject collected at the baseline visit for the PASI V2 instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results, matching the CRF item response text, are represented in RSORRES. This result is then represented as a standard numeric score in RSSTRESN and as a standard character representation in RSSTRESC.
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4 SDTM Mapping Strategy
This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, and RSSTRESN) should be populated.
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