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| Title | Psoriasis Area and Severity Index Version Fredriksson (PASI FREDRIKSSON) Supp V1.0
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| CDISC Reference | Clinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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| QRS Short Name | |
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| QRS Permission Status | Public Domain
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| Team | Psoriasis Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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| Supplement Version | 1.0
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| Status | DRAFT |
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| Date | 2022-07-24
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| 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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| 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 Fredriksson reference as the standard for responses.
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The PASI FREDRIKSSON 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 Fredriksson article as the stand standard for responses with some slight modifications from SME input. The PASI FREDRIKSSON 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 7-point scale. Subscores for each section of the body and a total score are also captured.
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