Revision History

© 2024 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Questionnaire on Smoking Urges-Brief (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 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 orimplement 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.

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. 

Revision History

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© 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.

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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.  (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. 

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.

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, which denotes a strong desire and inclination to smoke where smoking is perceived as rewarding for active smokers, is represented by the average score of items 1, 3, 6, 7, and 10. Factor 2, which denotes the anticipation of relief from the negative effects of smoking and the urgent desire to smoke, is represented by the average score of items 4, 8, and 9. The General Factor Scale presents a total urges score and is represented by the overall average score derived from all 10 items.

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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. 

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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"

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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.

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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.

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 contains 10 items and is intended to represent 2 factors and a general factor. The factor 1 scale is represented by the average score of items 1, 3, 6, 7, and 10; 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; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.  All other numeric values are stored in QSORRES, 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.
3. For questionnaire items QSTESTCD = "QSUB0101" to QSTESTCD ="QSUB0110", QSMETHOD is populated with "NUMERICAL RATING SCALE 11-POINT". The numeric rating scale represents the item-level ratings from 0 = "Strongly Disagree" to 100 = "Strongly Agree" in increments of 10.
4. 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 "RIGHT NOW" (QSEVINTX = "RIGHT NOW").
5. 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.

6. The QSU-BRIEF instrument includes an overall score and 2 subscoresthat 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 sponsor's responsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.

7. 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 and VISITNUM = 2 for the QSU-BRIEF instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All 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.

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.

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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 qualifier, timing, result, and unit fields is provided in Section 4, SDTM Mapping Strategy. (Note: Only the result field is always used. Include qualifier, timing, and unit fields as needed and remove this note.)

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 QSCAT. All 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.

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