Revision History

© 2023 2024 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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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.

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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.

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

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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 the two factors contained in the longer, 32-item QSU (Tiffany & Drobes, 1991). Factor 1 Scale 2 factors and a general factor. The factor 1 scale is represented by the average score of items 1, 3, 6, 7, and 10, and ; the Factor factor 2 Scale scale is represented by the average score of items 4, 8, and 9. The General Factor Scale general factor scale is represented by the overall average score derived from all 10 items.

1. The original scores include 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.  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.The low and high anchor text is stored in QSORRES with the numeric values stored in QSSTRESC 
3. and QSSTRESN.  All other numeric values are stored in QSORRES, QSSTRESC and QSSTRESNFor 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 "DURING QUESTIONNAIRE COMPLETIONRIGHT NOW" (QSEVINTX = "DURING QUESTIONNAIRE COMPLETIONRIGHT 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 two 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 sponsors 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.

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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.

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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.

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