Information for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

Title

Psoriasis Area and Severity Index Version EMA (PASI EMA)

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

PASI EMA

QRS Permission StatusPublic Domain
TeamPsoriasis Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2022-07-24
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 EMA guidelines for Psoriasis as the standard for responses.


Revision History

DateVersion
2022-07-241.0 Draft

© 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 EMA (PASI EMA) instrument. 

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 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 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 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.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.

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 EMA in 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.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values. 

Information for Reviewers

The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF.

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 EMA:


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 EMA are listed below.

The PASI EMA is a tool used to assess the severity of psoriasis. The PASI EMA 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 = "No symptoms"). For the PASI EMA, 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 EMA guidelines using the symptom terms "erythema/redness," "thickness/induration," and "desquamation/scaling." Per subject-matter expert recommendations, these terms were included even though not all of them were referenced in the EMA 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 = "<10%"). 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 EMA 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 EMA 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.

3.2 Example for the PASI EMA RS Domain Model

The PASI EMA example below shows the terminology used to implement the instrument in the RS domain. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results, matching the CRF item response text, are represented in RSORRES. This result is then represented as a standard numeric score in RSSTRESN and as a standard character representation in RSSTRESC.

We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.


The table represents the items from the PASI EMA instrument.

Rows 1-16:Show the symptom and area responses for the baseline visit.
Rows 17-29:Show the subscores and total scores for the baseline visit.
Rows 30-59:Show the subject was not evaluated on this instrument at visit 2. Since the reason for not completing the visit was collected, the date is included in RSDTC for when the visit was planned.
$titleHtml

rs.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSSTRESNRSSTATRSREASNDRSLOBXFLVISITNUMRSDTC
1STUDYXRS2324-P00011PASI0401PASI04-Head: Erythema/Redness
PASI EMASlight11

Y12015-05-15
2STUDYXRS2324-P00012PASI0402PASI04-Head: Thickness/Induration
PASI EMANo symptoms00

Y12015-05-15
3STUDYXRS2324-P00013PASI0403PASI04-Head: Desquamation/Scaling
PASI EMANo symptoms00

Y12015-05-15
4STUDYXRS2324-P00014PASI0404PASI04-Head: Area Score
PASI EMA<10%11

Y12015-05-15
5STUDYXRS2324-P00015PASI0405PASI04-Up Extrem: Erythema/Redness
PASI EMAModerate22

Y12015-05-15
6STUDYXRS2324-P00016PASI0406PASI04-Up Extrem: Thickness/Induration
PASI EMASlight11

Y12015-05-15
7STUDYXRS2324-P00017PASI0407PASI04-Up Extrem: Desquamation/Scaling
PASI EMAModerate22

Y12015-05-15
8STUDYXRS2324-P00018PASI0408PASI04-Up Extrem: Area Score
PASI EMA30 - 49%33

Y12015-05-15
9STUDYXRS2324-P00019PASI0409PASI04-Trunk: Erythema/Redness
PASI EMANo symptoms00

Y12015-05-15
10STUDYXRS2324-P000110PASI0410PASI04-Trunk: Thickness/Induration
PASI EMANo symptoms00

Y12015-05-15
11STUDYXRS2324-P000111PASI0411PASI04-Trunk: Desquamation/Scaling
PASI EMANo symptoms00

Y12015-05-15
12STUDYXRS2324-P000112PASI0412PASI04-Trunk: Area Score
PASI EMA< 10%11

Y12015-05-15
13STUDYXRS2324-P000113PASI0413PASI04-Low Extrem: Erythema/Redness
PASI EMASlight11

Y12015-05-15
14STUDYXRS2324-P000114PASI0414PASI04-Low Extrem: Thickness/Induration
PASI EMASlight11

Y12015-05-15
15STUDYXRS2324-P000115PASI0415PASI04-Low Extrem: Desquamation/Scaling
PASI EMASlight11

Y12015-05-15
16STUDYXRS2324-P000116PASI0416PASI04-Low Extrem: Area Score
PASI EMA10 - 29%22

Y12015-05-15
17STUDYXRS2324-P000117PASI0417PASI04-Head: Sum of Symptom Scores
PASI EMA111

Y12015-05-15
18STUDYXRS2324-P000118PASI0418PASI04-Head: Sum X Area
PASI EMA111

Y12015-05-15
19STUDYXRS2324-P000119PASI0419PASI04-Head: Sum X Area X 0.1
PASI EMA0.10.10.1

Y12015-05-15
20STUDYXRS2324-P000120PASI0420PASI04-Up Extrem: Sum of Symptom Scores
PASI EMA555

Y12015-05-15
21STUDYXRS2324-P000121PASI0421PASI04-Up Extrem: Sum X Area
PASI EMA151515

Y12015-05-15
22STUDYXRS2324-P000122PASI0422PASI04-Up Extrem: Sum X Area X 0.2
PASI EMA333

Y12015-05-15
23STUDYXRS2324-P000123PASI0423PASI04-Trunk: Sum of Symptom Scores
PASI EMA000

Y12015-05-15
24STUDYXRS2324-P000124PASI0424PASI04-Trunk: Sum X Area
PASI EMA000

Y12015-05-15
25STUDYXRS2324-P000125PASI0425PASI04-Trunk: Sum X Area X 0.3
PASI EMA000

Y12015-05-15
26STUDYXRS2324-P000126PASI0426PASI04-Low Extrem: Sum of Symptom Scores
PASI EMA333

Y12015-05-15
27STUDYXRS2324-P000127PASI0427PASI04-Low Extrem: Sum X Area
PASI EMA666

Y12015-05-15
28STUDYXRS2324-P000128PASI0428PASI04-Low Extrem: Sum X Area X 0.4
PASI EMA2.42.42.4

Y12015-05-15
29STUDYXRS2324-P000129PASI0429PASI04-Total Sum
PASI EMA5.55.55.5

Y12015-05-15
30STUDYXRS2324-P000130PASI0401PASI04-Head: Erythema/Redness
PASI EMA


NOT DONEREFUSED
22015-06-14
31STUDYXRS2324-P000131PASI0402PASI04-Head: Thickness/Induration
PASI EMA


NOT DONEREFUSED
22015-06-14
32STUDYXRS2324-P000132PASI0403PASI04-Head: Desquamation/Scaling
PASI EMA


NOT DONEREFUSED
22015-06-14
...














59STUDYXRS2324-P000159PASI0429PASI04-Total Sum
PASI EMA


NOT DONEREFUSED
22015-06-14
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

4 SDTM Mapping Strategy

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


RSTESTCD = "PASI0401" RSTEST = "PASI04-Head: Erythema/Redness"

RSTESTCD = "PASI0402" RSTEST = "PASI04-Head: Thickness/Induration"

RSTESTCD = "PASI0403" RSTEST = "PASI04-Head: Desquamation/Scaling"

RSTESTCD = "PASI0405" RSTEST = "PASI04-Up Extrem: Erythema/Redness"

RSTESTCD = "PASI0406" RSTEST = "PASI04-Up Extrem: Thickness/Induration"

RSTESTCD = "PASI0407" RSTEST = "PASI04-Up Extrem: Desquamation/Scaling"

RSTESTCD = "PASI0409" RSTEST = "PASI04-Trunk: Erythema/Redness"

RSTESTCD = "PASI0410" RSTEST = "PASI04-Trunk: Thickness/Induration"

RSTESTCD = "PASI0411" RSTEST = "PASI04-Trunk: Desquamation/Scaling"

RSTESTCD = "PASI0413" RSTEST = "PASI04-Low Extrem: Erythema/Redness"

RSTESTCD = "PASI0414" RSTEST = "PASI04-Low Extrem: Thickness/Induration"

RSTESTCD = "PASI0415" RSTEST = "PASI04-Low Extrem: Desquamation/Scaling"

RSORRESRSSTRESCRSSTRESN
No symptoms00
Slight11
Moderate22
Marked33
Very marked44


RSTESTCD = "PASI0404" RSTEST = "PASI04-Head: Area Score"

RSTESTCD = "PASI0408" RSTEST = "PASI04-Up Extrem: Area Score"

RSTESTCD = "PASI0412" RSTEST = "PASI04-Trunk: Area Score"

RSTESTCD = "PASI0416" RSTEST = "PASI04-Low Extrem: Area Score"

RSORRESRSSTRESCRSSTRESN
<10%11
10% - 29%22
30% - 49%33
50% - 69%44
70% - 89%55
90% - 100%66


End of Document

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