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color coding

Green = Recent FDA Changes

Pink = Instructional information for developers

Blue = Text can change from supplement to supplement based on the instrument

Black = Standard template language

Instructions on how to use this template

  1. Copy QS Template page and move to the Initial development (not ready for review) page. Please DO NOT OVERWRITE the template pages.
    1. If the supplement is based on a measurement system, such as PRO-CTCAE V1.0, FACIT, PROMIS, etc., replace the word instrument with measurement system throughout the supplement.
  2. The "–" in this template represents the domain implemented for the instrument. This is replaced with the 2-character domain abbreviation of FT, QS, or RS that is used for the instrument.
  3. Change the title of the page as follows:
    1. Remove 'Copy of QRS Supplement Template - '.
    2. Replace 'Name of QRS Instrument' with the full name of the QRS instrument the supplement is being created for.
    3. Change 'QRS Short_Name' to the short name (--CAT) for the current instrument.
  4. Update the information in the Page Properties block below as indicated in the block below.
    1. The supplement version number in the header section will be 'v1' if there has never been a supplement for the instrument before. Otherwise, increment as appropriate.
    2. If the CRF was copyright approved, keep 'Approved'; otherwise change 'Approved' to 'Public Domain'.
  5. Replace 'Title' and 'QRS Short_Name' throughout the document with the title and short name of the instrument that the supplement is being created for.
  6. Replace royal blue text with information pertaining to the instrument the supplement is being created for. Delete royal blue text which does not apply to the new instrument.
  7. Unless otherwise noted, text in black applies to all QRS Supplements and should not be deleted, but should be examined carefully and revised as appropriate based on the specific instrument supplement as needed. Any changes need to be in blue font to stand out for review.
  8. Change QS to RS or FT and 'Questionnaires' to 'Disease Response and Clin Classification' or 'Functional Tests' as appropriate.
  9. Remove all information blocks, except for the one immediately below this called 'Information for Reviewers'.
  10. Keep changes in blue for ease throughout internal and public review. Once the supplement has gone thru public review and all comments are resolved, change all text color to black except for hyperlinks.
  11. Arabic numerals (0, 1, 2, 3, etc.) are used to express numbers in most circumstances. Exceptions are the following: 
    • Numbers that begin a sentence, title, subtitle, or heading 
    • Common fractions 

    • Accepted usage such as idiomatic expressions and numbers used as pronouns 

    • Other uses of “one” in running text (e.g., when meaning "a")
    • Ordinals first through ninth
    • Numbers spelled out in quotes or published titles.

Information for Reviewers

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

Title

Brief Questionnaire of Smoking Urges (QSU-BRIEF)

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

QSU-BRIEF

QRS Permission StatusApproved
TeamStandards team QRS instrument is being developed for (e.g., Major Depressive Disorder Standards Team), if applicable, and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2024-01-05
Notes to Readers
  • This supplement is available 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 IssuesOnly include this row to describe any known issues related to the supplement. If there are no issues, this row can be deleted.


Revision History

DateVersion
2024-01-051.0 Draft

© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Brief Questionnaire of Smoking Urges instrument.

For CRFs that are created by CDISC with SME input, use this statement:  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 (TA or instrument) 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.  (note that if you use this statement, then QRS is not spelled out for the first time until where noted below.) (the related reference article needs to be included as a footnote on the CDISC created CRF)

For CRFs that are created by CDISC based on articles, use this statement. Include the 1st sentence for articles that don't have a CRF.  If the 1st sentence is NOT included, then spell out "case report form (CRF)" in the 2nd sentence:  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.  (note that if you use this statement, then QRS is not spelled out for the first time until where noted below.)

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

The 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 implement 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.  (Include this line only for supplements that the US FDA will be reviewing.  Please DO NOT MODIFY the sentence.)

2 Copyright Status

Stephen T Tiffany owns the copyright for the QSU-BRIEF instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. (For supplements that are to be distributed by the copyright holder, add: Name of copyright holder (e.g., Board of Regents of The University of Texas System) will distribute the CDISC supplement package to sponsors when they are approved to use this instrument.) Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.

Questionnaire on Smoking Urges-Brief (QSU-BRIEF) (Cox, L. S., Tiffany, S. T., & Christen, A. G. (2001). Evaluation of the brief questionnaire of smoking urges (QSU-Brief) in laboratory and clinical settings. Nicotine and Tobacco Research, 3, 7-16). These materials discuss and/or include the Questionnaire on Smoking Urges-Brief (QSU-BRIEF), which are owned exclusively by Stephen T Tiffany. No part of the Questionnaire on Smoking Urges-Brief (QSU-BRIEF) may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of  Stephen T Tiffany and payment of any applicable fees. Copyright Stephen T Tiffany. All rights reserved.

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.

CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

CDISC acknowledges Stephen T Tiffany for the approval to include the QSU-BRIEF in the CDISC data standards.

References for the QSU-BRIEF:

  • Cox, L. S., Tiffany, S. T., and Christen, A. G. Evaluation of the brief questionnaire of smoking urges (QSU-BRIEF) in laboratory and clinical settings. Nicotine and Tobacco Research, 3:7-16, 2001.
  • Tiffany, S. T., and Drobes, D. J. The development and initial validation of a questionnaire on smoking urges. British Journal of Addition, 86:1467-1476, 1991.

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the QRS QSU-BRIEF are listed below.

The QRS QSU-BRIEF is a self-report instrument used to assess the severity of craving to smoke.The QSU-Brief Form is intended to represent the two factors contained in the longer, 32-item QSU (Tiffany & Drobes, 1991). This brief form contains 10 items, each rated on a 100-point scale in increments of 10 ranging from 0 = "Strongly Disagree" to 100 = "Strongly Agree". Factor 1 is represented by the average score of items 1, 3, 6, 7, and 10, and denotes a strong desire and inclination to smoke where smoking is perceived as rewarding for active smokers. Factor 2 is represented by the average score of items 4, 8, and 9, and denotes the anticipation of relief from the negative effects of smoking and the urgent desire to smoke, . The General Factor Scale presents a total urges score and is represented by the overall average score derived from all 10 items.

  1. The original scores include a numeric rating (0-100) in increments of 10, and a definition of what the ratings represent at the scale anchors (e.g., 0 = "Strongly Disagree" and 100 = "Strongly Agree"). For the QRS QSU-BRIEF, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN. 

  2. Numeric rating scales used within a questionnaire with a range of text and numeric values are indicated in the SUPPQS domain with:

    QNAM="QSANTXLO"     QNAM="QSANTXHI"

    QNAM="QSANVLLO"     QNAM="QSANVLHI"
    By storing this information in SUPPQS, it is available for interpretation purposes.
    The low and high anchor text is stored in QSORRES with the low and high numeric values stored in QSSTRESC and QSSTRESN.  All other numeric values are stored in QSORRES, QSSTRESC and QSSTRESN.
  3. The time period of evaluation for the QRS QSU-BRIEF is populated in the QSEVINTX field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the QRS QSU-BRIEF is "DURING QUESTIONNAIRE COMPLETION" (QSEVINTX = "DURING QUESTIONNAIRE COMPLETION").
  4. Records are created in qs.xpt for every instrument item
    1. For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE". If the reason is known then that reason is represented in QSREASND (e.g., QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.

    2. Due to the variability of copyright holder and public domain derived subscore and overall score generation processes, records are not included for derived subscores or overall scores that are not provided.
  5. The QRS QSU-BRIEF instrument includes an overall score and two subscores that are considered as captured data on the instrument and is 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 Stephen T Tiffany.

    1. Subscores and overall scores are represented in--ORRES, --STRESC, and --STRESN.
    2. If subscores or overall scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible. It is the sponsors repsonsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.
  6. Terminology

    1. QSCAT, QSTESTCD, QSTEST, QSORRES, QSSTRESC, and QSSTRESN values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the result fields is provided in Section 4, SDTM Mapping Strategy.

3.2 Example for the QRS QSU-BRIEF QS Domain Model

The QRS QSU-BRIEF example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline visit for the QRS QSU-BRIEF instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCATAll original results, matching the CRF item response text, are represented in QSORRES. This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.

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 QRS QSU-BRIEF instrument.

Rows 1-13:Represent the questions from the QSU-Brief Scale for subject 2324-P0001 at visit 1. Row 11 represents the subscale total score for Factor 1, row 12 represents subscale total score for Factor 2 and row 13 represents the Overall Global Score.
Row 14:Represent the missing datsa from the QSU-BRIEF Scale for subject 2324-P0001 at visit 2. Since the reason for not completing the visit was collected, the date is included in --DTC for when the visit was planned. As no observation is provided evaluation interval QSEVINTX is missing. NEED TO CHECK THIS.

qs.xpt

qs.xpt

RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSSTATQSREASNDQSLOBXFLVISITNUMQSDTCQSEVINTX
1STUDYXQS2324-P00011QSUB0101QSUB01-Desire Cigarette Right NowQSU-BRIEF909090

Y12015-05-15DURING QUESTIONNAIRE COMPLETION
2STUDYXQS2324-P00012QSUB0102QSUB01-Nothing Better Than Cigarette NowQSU-BRIEF505050

Y12015-05-15DURING QUESTIONNAIRE COMPLETION
3STUDYXQS2324-P00013QSUB0103QSUB01-Probably Would Smoke NowQSU-BRIEF707070

Y12015-05-15DURING QUESTIONNAIRE COMPLETION
4STUDYXQS2324-P00014QSUB0104QSUB01-Control Things Better Could SmokeQSU-BRIEF707070

Y12015-05-15DURING QUESTIONNAIRE COMPLETION
5STUDYXQS2324-P00015QSUB0105QSUB01-All I Want Right Now Is CigaretteQSU-BRIEF505050

Y12015-05-15DURING QUESTIONNAIRE COMPLETION
6STUDYXQS2324-P00016QSUB0106QSUB01-Have an Urge for a CigaretteQSU-BRIEFStrongly Agree100100

Y12015-05-15DURING QUESTIONNAIRE COMPLETION
7STUDYXQS2324-P00017QSUB0107QSUB01-A Cigarette Would Taste Good NowQSU-BRIEF808080

Y12015-05-15DURING QUESTIONNAIRE COMPLETION
8STUDYXQS2324-P00018QSUB0108QSUB01-Do Anything for a Cigarette NowQSU-BRIEF909090

Y12015-05-15DURING QUESTIONNAIRE COMPLETION
9STUDYXQS2324-P00019QSUB0109QSUB01-Smoking Make Me Less DepressedQSU-BRIEF808080

Y12015-05-15DURING QUESTIONNAIRE COMPLETION
10STUDYXQS2324-P000110QSUB0110QSUB01-Going Smoke as Soon as PossibleQSU-BRIEFStrongly Disagree00

Y12015-05-15DURING QUESTIONNAIRE COMPLETION
11STUDYXQS2324-P000111QSUB0111QSUB01-Factor 1 ScaleQSU-BRIEF686868

Y12015-05-15DURING QUESTIONNAIRE COMPLETION
12STUDYXQS2324-P000112QSUB0112QSUB01-Factor 2 ScaleQSU-BRIEF808080

Y12015-05-15DURING QUESTIONNAIRE COMPLETION
13STUDYXQS2324-P000113QSUB0113QSUB01-General Factor ScaleQSU-BRIEF686868

Y12015-05-15DURING QUESTIONNAIRE COMPLETION
14STUDYXQS2324-P00011QSUB0101QSUB01-Desire Cigarette Right NowQSU-BRIEF


NOT DONESUBJECT REFUSED
22015-05-15

Dataset Debug Message

Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The anchor range text and numeric values for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
STUDYXQS2324-P0001QSTESTCDQSUB0106QSANTXLOAnchor Text LowStrongly DisagreeCRF
STUDYXQS2324-P0001QSTESTCDQSUB0110QSANTXHIAnchor Text HighStrongly AgreeCRF
STUDYXQS2324-P0001QSTESTCDQSUB0106QSANVLLOAnchor Numeric Value Low0CRF
STUDYXQS2324-P0001QSTESTCDQSUB0110QSANVLHIAnchor Numeric Value High100CRF

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 QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

"All QSTESTCDs"

QSORRESQSSTRESCQSSTRESN
Strongly Disagree00
101010
202020
303030
404040
505050
606060
707070
808080
909090
Strongly Agree100100


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.

QNAMQLABELQVAL
QSANTXLOAnchor Text LowStrongly Disagree
QSANTXHIAnchor Text HighStrongly Agree
QSANVLLOAnchor Numeric Value Low0
QSANVLHIAnchor Numeric Value High100


End of Document

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