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Revision History

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© 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

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Revision History

© 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 Feldman (PASI FELDMAN) 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.

There is no known standard case report form (CRF) available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. This is not an endorsement of the instrument. The creation of this instrument was based on published articles describing the instrument. Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/items and responses as described on the CRF.

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which

There is no known standard case report form (CRF) available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. This is not an endorsement of the instrument. The creation of this instrument was based on input from PASI V2 subject matter experts. Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/items and responses as described on the CRF.

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC Quesionnaires, Ratings and Scales (QRS)documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/standards/aboutfoundational/bylawssdtmig.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC Questionnaires, Ratings and Scales (QRS)documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

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 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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Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

Reference for the PASI V2FELDMAN:

• Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials.

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• Ann Rheum Dis. 2005;64(Suppl 2):

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• ii65–ii68.
• CDISC believes this instrument to be in the public domain, but you should perform your own assessment.

3 The RS Domain Model

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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 FELDMAN are listed below.

The PASI V2FELDMAN 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 the industry. This supplement uses the Feldman article as the standard for responses. The PASI V2 breaks FELDMAN divides the body up into 4 sections (i.e.,  headhead, trunk, upper extremityextremities, lower extremityextremities) 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 (i.e., erythema/redness, thickness/induration, desquamation/scaling) include a numeric rating (0-4) and a definition of what is represented by the rating (e.g., 0 = "None"). For the PASI V2FELDMAN, 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 Feldman reference article.
      The Feldman article uses the Feldman article using the symptom terms "erythema/redness," , "thickness/induration," and "scale". However, the terms "redness", "thickness" and "desquamation" are also used regularly, therefore, both version of the symptom terms are used on the CDISC created CRF and in the terminology for RSTESTdesquamation/scaling." 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 Involvement0 (clear)"). 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 FELDMAN 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.

3.2 Example for the PASI

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FELDMAN RS Domain Model

The PASI V2 FELDMAN 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 with preferred terminology in RSORRES. This result is then transformed into the represented as a standard numeric score in RSSTRESN and as a standard character representation of the standard numeric score in RSSTRESC.

The table represents the items from the PASI V2 instrumentFELDMAN instrument.

The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes):

Text that would remain unchanged has been left in black:

The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

4 SDTM Mapping Strategy

4 SDTM Mapping Strategy

This section is This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS RS domain. It also provides guidance on how the result variables (QSORRESRSORRES, QSSTRESCRSSTRESC, and QSSTRESNRSSTRESN) should be populated.

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For QRS instruments with subcategories:

When subcategories are used on an instrument, a table with the following introduction information should appear before the mappings for results.

QSSCAT alignment with QSTESTCD

As stated in Section 3.1 assumptions, items on the QRS Short_Name are grouped into subcategories. The table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

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If all items have the same original result values, with the same standardized character and numeric values, then only include one table showing the values of QSORRES/QSSTRESC/QSSTRESN and put "All QSTESTCDs" (title case "All", and in quotes) above the table:

"All QSTESTCDs"

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Similarly, if some, but not all, QSTESTCDs share the same original result and standardized values, then the QSTESTCD and corresponding QSTEST values are put in a list above the table rather than providing a separate table for each QSTESTCD/QSTEST.

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If there are responses that correspond to non-consecutive items or 1-7 consecutive items, include the test codes and test names above the table with the responses as follows:

QSTESTCD = "test code 1" QSTEST = "test name 1"

QSTESTCD = "test code 4" QSTEST = "test name 4"

QSTESTCD = "test code 5" QSTEST = "test name 5"

QSTESTCD = "test code 6" QSTEST = "test name 6"

QSTESTCD = "test code 7" QSTEST = "test name 7"

QSTESTCD = "test code 8" QSTEST = "test name 8"

QSTESTCD = "test code 15" QSTEST = "test name 15"

QSTESTCD = "test code 22" QSTEST = "test name 22"

QSTESTCD = "test code 27" QSTEST = "test name 27"

QSTESTCD = "test code 29" QSTEST = "test name 29"

RSTESTCD = "PASI0201" RSTEST = "PASI02-Head: Erythema/Redness"

RSTESTCD = "PASI0202" RSTEST = "PASI02-Head: Thickness/Induration"

RSTESTCD = "PASI0203" RSTEST = "PASI02-Head: Desquamation/Scaling"

RSTESTCD = "PASI0205" RSTEST = "PASI02-Up Extrem: Erythema/Redness"

RSTESTCD = "PASI0206" RSTEST = "PASI02-Up Extrem: Thickness/Induration"

RSTESTCD = "PASI0207" RSTEST = "PASI02-Up Extrem: Desquamation/Scaling"

RSTESTCD = "PASI0209" RSTEST = "PASI02-Trunk: Erythema/Redness"

RSTESTCD = "PASI0210" RSTEST = "PASI02-Trunk: Thickness/Induration"

RSTESTCD = "PASI0211" RSTEST = "PASI02-Trunk: Desquamation/Scaling"

RSTESTCD = "PASI0213" RSTEST = "PASI02-Low Extrem: Erythema/Redness"

RSTESTCD = "PASI0214" RSTEST = "PASI02-Low Extrem: Thickness/Induration"

RSTESTCD = "PASI0215" RSTEST = "PASI02-Low Extrem: Desquamation/Scaling"

RSTESTCD = "PASI0204" RSTEST = "PASI02-Head: Area Score"

RSTESTCD = "PASI0208" RSTEST = "PASI02-Up Extrem: Area Score"

RSTESTCD = "PASI0212" RSTEST = "PASI02-Trunk: Area Score"

RSTESTCD = "PASI0216" RSTEST = "PASI02-Low Extrem: Area Score"

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Omit the QSSTRESN column when it is not applicable to the dataset.

QSTESTCD = "test code" QSTEST = "test name"

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For responses that are for 8 or more consecutive items, an override label should be used in QRS Maker to show the items that are included as follows:

QSTESTCD = "first test code in sequence" QSTEST = "first test name in sequence" through

QSTESTCD = "last test code in sequence" QSTEST = "last test name in sequence"

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5 Supplemental Qualifier Name Codes

The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires (SUPPQS) special purpose dataset.

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End of Document