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Title

Psoriasis Area and Severity Index Version Bozek (PASI BOZEK)

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

PASI BOZEK

QRS Permission StatusPublic Domain
TeamPsoriasis Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2022-0607-3024
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.
Known Issue(s)
  • Version 1 of the Psoriasis Area and Severity Index CDISC Controlled Terminology (RSCAT=PASI with synonym=PASI01) is scheduled for deprecation and an associated QRS supplement will not be released.
  • There is not general agreement between industry, regulators, and academia on a standard set of responses for the PASI. Therefore, CDISC has created separate terminology and supplements for multiple references with different sets of responses for the PASI. This supplement uses the Bozek reference as the standard for responses.

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Revision History

DateVersion
2022-0607-30241.0 Draft

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

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The PASI BOZEK is a tool used to assess the severity of psoriasis. However, there is no standard set of responses for the PASI that is used throughout industry. This supplement uses the Bozek article as the stand standard for responses. The PASI BOZEK divides the body 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 6-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 BOZEK, RSORRES is populated with the text description; 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." . Per subject-matter expert recommendations, redness was included with erythema even though redness is not referenced in the Bozek article.
  2. The scale points for the area include a numeric rating (1-6) and a definition of what is represented by the rating (e.g., 1 = "0 - 9%"). 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.

  3. The PASI BOZEK 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 Bozek 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, that reason is represented in RSREASND (e.g., RSREASND = "REFUSED"). If the reason is unknown, 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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