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Title

Psoriasis Area and Severity Index (PASI)

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

PASI

QRS Permission StatusPublic Domain
TeamPsoriasis Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2020-0204-2829
NotesThis 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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  1. The scale points for the symptoms (i.e., erythema, infiltration, desquamation) include a numeric rating (0-4) and a definition of what is represented by the rating (e.g., 0 = "None"). For the PASI, 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 input from subject-matter experts and the original Fredrikkson reference article.
    2. The Fredrikkson article is the original reference for the PASI; however, the Symptom Score response choices have changed over time to "None", "Slight", "Moderate", "Severe", and "Very Severe" as supported in the Feldman reference above. CDISC subject-matter experts have chosen to use these responses as the data standard.
    3. explain trunk score
  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 PASI, 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 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.

    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 written on a CRF 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).

  4. 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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