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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

Questionnaire on Smoking Urges-Brief (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
TeamTobacco Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2024-01-07
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
2024-01-071.0 Draft

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

1 Introduction

This document describes the CDISC implementation of the Brief Questionnaire on Smoking Urges (QSU-BRIEF) instrument.

CDISC did not modify this questionnaires, ratings, and scales (QRS) instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

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.

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. 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.

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 QSU-BRIEF are listed below.

The 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 Scale is represented by the average score of items 1, 3, 6, 7, and 10, and the Factor 2 Scale is represented by the average score of items 4, 8, and 9. The General Factor Scale 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 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. The numeric rating scale used in the QSU-BRIEF includes text and numeric values as 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 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 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 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 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 QSORRES, QSSTRESC, and QSSTRESN.
    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 responsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.
  6. Terminology

    1. QSCAT, QSTESTCD, and QSTEST 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 QSU-BRIEF QS Domain Model

The 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 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.

The table represents the items from the QSU-BRIEF instrument.

Row 2:Represent the missing data from the QSU-BRIEF Scale for subject 2324-P0001 at visit 1. Since the reason for not completing the visit was collected, the date is included in QSDTC for when the visit was planned.
Rows 11-13:Row 11 represents the subscale score for Factor 1 Scale, row 12 represents subscale score for Factor 2 Scale, and row 13 represents the General Factor Scale.

qs.xpt

qs.xpt

RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSSTATQSREASNDQSLOBXFLVISITNUMQSDTCQSEVINTX

1

STUDYX

QS

2324-P0001

1

QSUB0101

QSUB01-Desire Cigarette Right Now

QSU-BRIEF

90

90

90



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

2

STUDYX

QS

2324-P0001

2

QSUB0102

QSUB01-Nothing Better Than Cigarette Now

QSU-BRIEF




NOT DONE

SUBJECT REFUSED

Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

3

STUDYX

QS

2324-P0001

3

QSUB0103

QSUB01-Probably Would Smoke Now

QSU-BRIEF

70

70

70



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

4

STUDYX

QS

2324-P0001

4

QSUB0104

QSUB01-Control Things Better Could Smoke

QSU-BRIEF

70

70

70



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

5

STUDYX

QS

2324-P0001

5

QSUB0105

QSUB01-All I Want Right Now Is Cigarette

QSU-BRIEF

50

50

50



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

6

STUDYX

QS

2324-P0001

6

QSUB0106

QSUB01-Have an Urge for a Cigarette

QSU-BRIEF

Strongly Agree

100

100



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

7

STUDYX

QS

2324-P0001

7

QSUB0107

QSUB01-A Cigarette Would Taste Good Now

QSU-BRIEF

80

80

80



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

8

STUDYX

QS

2324-P0001

8

QSUB0108

QSUB01-Do Anything for a Cigarette Now

QSU-BRIEF

90

90

90



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

9

STUDYX

QS

2324-P0001

9

QSUB0109

QSUB01-Smoking Make Me Less Depressed

QSU-BRIEF

80

80

80



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

10

STUDYX

QS

2324-P0001

10

QSUB0110

QSUB01-Going Smoke as Soon as Possible

QSU-BRIEF

Strongly Disagree

0

0



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

11

STUDYX

QS

2324-P0001

11

QSUB0111

QSUB01-Factor 1 Scale

QSU-BRIEF

68

68

68



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

12

STUDYX

QS

2324-P0001

12

QSUB0112

QSUB01-Factor 2 Scale

QSU-BRIEF

80

80

80



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

13

STUDYX

QS

2324-P0001

13

QSUB0113

QSUB01-General Factor Scale

QSU-BRIEF

68

68

68



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

$warningHtml

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.

$titleHtml

suppqs.xpt

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

Dataset Debug Messages

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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