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Title

Psoriasis Area and Severity Index Version 2 (PASI V2)

CDISC ReferenceClinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

PASI V2

QRS Permission StatusPublic Domain
TeamPsoriasis Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2022-0304-2106
Notes
  • This supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.


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Revision History

DateVersion
2022-0305-21061.0 Draft

© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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Info
titleReviewers input requested

CDISC would appreciate supplement reviewer’s reviewers' input on their experience in using the Psoriasis Area and Severity Index PASI V2 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:

  • Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005;64(Suppl 2):ii65–ii68.
    • Responses for symptoms are: none, slight, mild, moderate, severe.
  • Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839. PMID: 357213.
    • Responses for symptoms are: none, slight, moderate, striking, exceptionally striking.
  • EMA guideline on Clinical Investigation of Medicinal Products Indicated for the Treatment of Psoriasis (https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-indicated-treatment-psoriasis_en.pdf)
    • Responses for symptoms are based off on Fredriksson (no symptoms, slight, moderate, marked, very marked) and are grouped as: mild to moderate, moderate, moderate to severe, and severe. 

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”“undetermined.” The supplement will allow a sponsor’s list of responses, like as was done in the CDISC published in the PGI and CGI supplements.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

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The PASI V2 is a tool used to assess the severity of psoriasis. The PASI V2 breaks divides the body up into 4 sections (i.e., head, trunk, upper extremities, lower extremities) and assesses symptom severity and the percentage of each area affected by psoriasis. The symptoms are rated on a 5-point scale and the area is rated on a 7-point scale. Subscores for each section of the body and a total score are also captured.

  1. 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 while ; the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.

    1. CDISC created a CRF based on the Feldman article using the symptom terms "erythema/redness", "thickness/induration", and "desquamation/scaling". As SMEs have recommended, we included desquamation Per subject-matter expert recommendations, desquamation was included with scaling even though desquamation is not referenced in the Feldman article.
  2. 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 = "No Involvement"). For the area, RSORRES is populated with the text description while ; the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.

  3. 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.

    1. 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).

    2. If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.

  4. Records are created in rs.xpt for every item on the instrument: 

    1. For items with no data, RSORRES, RSSTRESC, and RSSTRESN are all missing and RSSTAT = "NOT DONE".  If the reason is known then , that reason is represented in RSREASND (e.g., RSREASND = "REFUSED"). If the reason is unknown, then RSSTAT = "NOT DONE" and RSREASND is missing.

  5. Terminology

    1. RSCAT, RSTESTCD, and RSTEST values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.

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