Info |
---|
|
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 |
Info |
---|
title | 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. |
Page properties |
---|
Title | Brief Questionnaire of on Smoking Urges-Brief (QSU-BRIEF) |
---|
CDISC Reference | Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
---|
QRS Short Name | |
---|
QRS Permission Status | Approved |
---|
Team | Tobacco Standards Teamand CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
---|
Supplement Version | 1.0 |
---|
Status | DRAFT |
---|
Date | 2024-0104-0708 |
---|
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.
|
---|
|
Revision History
...
Revision History
Date | Version |
---|
2024-0104-0708 | 1.0 Draft |
© 2023 2024 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
1 Introduction
This document describes the CDISC implementation of the Brief the Questionnaire of 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 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 orimplement 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. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.
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 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.
...
Info |
---|
title | Information for Reviewers |
---|
|
The CRF is attached at the top of the Wikiwiki. When you click the paperclip image, you will find the file for the annotated CRF. |
...
CDISC acknowledges Stephen T. Tiffany for the approval to include the QSU-BRIEF in the CDISC data standards.
...
- 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 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 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 1, 3, 6, 7, and 10, and the Factor 2 Scale 4, 8, and 9. The general factor scale is represented by the overall average score of items 4, 8, and 9. The General Factor Scale is represented by the overall average score derived from all 10 items.derived from all 10 items.
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.
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.- 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.
- The time period of evaluation for the QSU-BRIEFThe 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").
- Records are created in qs.xpt for every instrument item:
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.
- 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.
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.
- Subscores and overall scores are represented in QSORRES, QSSTRESC, and QSSTRESN.
- 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.
Terminology
QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.
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.
...
Dataset wrap |
---|
|
Rowcaps |
---|
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. | Rows 14-26: | Represent the missing data from the QSU-BRIEF Scale for subject 2324-P0001 at visit 1VISITNUM = 2. Since the visit was missed, the reason for not completing the questionnaire at the visit was not collected, the and no date is included in QSDTC assumed for when the visit was plannedwould have occurred. | 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. |
|
|
Dataset wrap |
---|
|
|
STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
---|
Dataset2 |
---|
Dataset2 |
---|
Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSLOBXFL | VISITNUM | QSDTC | QSEVINTX |
---|
1 | Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSMETHOD | QSLOBXFL | VISITNUM | QSDTC | QSEVINTX |
---|
1 | STUDYX | QS | 2324-P0001 | 1 | QSUB0101 | QSUB01-Desire Cigarette Right Now | QSU-BRIEF | 90 | 90 | 90 |
|
| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 2015-05-15 | RIGHT NOW | 2 | STUDYX | QS | 2324-P0001 | 2 | QSUB0102 | QSUB01-Nothing Better Than Cigarette Now | QSU-BRIEF | 80 | 80 | 80 |
|
| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 2015-05-15 | RIGHT NOW | 3 | STUDYX | QS | 2324-P0001 | 3 | QSUB0103 | QSUB01-Probably Would Smoke Now | QSU-BRIEF | 70 | 70 | 70 |
|
| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 2015-05-15 | RIGHT NOW | 4 | STUDYX | QS | 2324-P0001 | 4 | QSUB0104 | QSUB01-Control Things Better Could Smoke | QSU-BRIEF | 70 | 70 | 70 |
|
| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 2015-05-15 | RIGHT NOW | 5 | 1QSUB0101Desire Cigarette All I Want Right Now Is Cigarette | QSU-BRIEF | 50 | 9090 | 50 |
|
| NUMERICAL RATING SCALE 11-POINT | 90DURING QUESTIONNAIRE COMPLETION | 22QSUB0102Nothing Better Than Cigarette NowHave an Urge for a Cigarette | QSU-BRIEF |
NOT DONE | SUBJECT REFUSEDStrongly Agree | 100 | 100 |
|
| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 2015-05-15 |
DURING QUESTIONNAIRE COMPLETION | 33QSUB0103Probably Smoke 7070 | 80 |
|
| NUMERICAL RATING SCALE 11-POINT | 70DURING QUESTIONNAIRE COMPLETION | 44QSUB0104Control Things Better Could SmokeDo Anything for a Cigarette Now | QSU-BRIEF | 7070 | 90 |
|
| NUMERICAL RATING SCALE 11-POINT | 70DURING QUESTIONNAIRE COMPLETION | 55QSUB0105All I Want Right Now Is CigaretteSmoking Make Me Less Depressed | QSU-BRIEF | 5050 | 80 |
|
| NUMERICAL RATING SCALE 11-POINT | 50DURING QUESTIONNAIRE COMPLETION | 66QSUB0106Have an Urge for a CigaretteGoing Smoke as Soon as Possible | QSU-BRIEF | Strongly | Agree100 | 0 |
|
| NUMERICAL RATING SCALE 11-POINT | 100DURING QUESTIONNAIRE COMPLETION | 77QSUB0107A Cigarette Would Taste Good Now808080DURING QUESTIONNAIRE COMPLETION | 88QSUB0108Do Anything for a Cigarette Now909090DURING QUESTIONNAIRE COMPLETION | 99QSUB0109Smoking Make Me Less DepressedGeneral Factor Scale | QSU-BRIEF | 808080DURING QUESTIONNAIRE COMPLETION | 1010QSUB0110Going Smoke as Soon as PossibleDesire Cigarette Right Now | QSU-BRIEF |
Strongly Disagree | 0 | 0 | Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETION | |
|
|
| NOT DONE |
|
|
| 2 |
|
| 15 | STUDYX | QS | 2324-P0001 | 15 | QSUB0102 | QSUB01-Nothing Better Than Cigarette Now | QSU-BRIEF |
|
|
| NOT DONE |
|
|
| 2 |
|
| 16 | 1111QSUB0111Factor 1 ScaleProbably Would Smoke Now | QSU-BRIEF |
68 | 68 | 68 | Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETION |
|
|
| NOT DONE |
|
|
| 2 |
|
| 17 | STUDYX | QS | 2324-P0001 | 17 | QSUB0104 | QSUB01-Control Things Better Could Smoke | QSU-BRIEF |
|
|
| NOT DONE |
|
|
| 2 |
|
| 18 | 1212QSUB0112Factor 2 ScaleAll I Want Right Now Is Cigarette | QSU-BRIEF |
80 | 80 | 80 | Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETION |
|
|
| NOT DONE |
|
|
| 2 |
|
| 19 | STUDYX | QS | 2324-P0001 | 19 | QSUB0106 | QSUB01-Have an Urge for a Cigarette | QSU-BRIEF |
|
|
| NOT DONE |
|
|
| 2 |
|
| 20 | 1313QSUB0113General Factor ScaleA Cigarette Would Taste Good Now | QSU-BRIEF | 686868Y1201505-15DURING QUESTIONNAIRE COMPLETION | |
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.
P0001 | 21 | QSUB0108 | QSUB01-Do Anything for a Cigarette Now | QSU-BRIEF |
|
|
| NOT DONE |
|
|
| 2 |
|
| 22 | STUDYX | QS | 2324-P0001 | 22 | QSUB0109 | QSUB01-Smoking Make Me Less Depressed | QSU-BRIEF |
|
|
| NOT DONE |
|
|
| 2 |
|
| 23 |
|
| QSTESTCD | QSUB0106 | QSANTXLO | Anchor Text Low | Strongly Disagree | CRFQSUB0110 | QSUB01-Going Smoke as Soon as Possible | QSU-BRIEF |
|
|
| NOT DONE |
|
|
| 2 |
|
| 24 | STUDYX | QS |
|
2324-P0001 | QSTESTCD | QSUB0110 | QSANTXHI | Anchor Text High | Strongly Agree | CRF | | 2324-P0001 | 24 | QSUB0111 | QSUB01-Factor 1 Scale | QSU-BRIEF |
|
|
| NOT DONE |
|
|
| 2 |
|
| 25 | STUDYX | QS | 2324-P0001 | 25 |
|
QSTESTCD | QSUB0106 | QSANVLLO | Anchor Numeric Value Low | 0 | QSUB0112 | QSUB01-Factor 2 Scale | QSU-BRIEF |
|
|
| NOT DONE |
|
|
| 2 |
|
| 26 |
|
CRFQSTESTCD | QSUB0110 | QSANVLHI | Anchor Numeric Value High | 100 | CRF | | 26 | QSUB0113 | QSUB01-General Factor Scale | QSU-BRIEF |
|
|
| NOT DONE |
|
|
| 2 |
|
|
|
Dataset wrap |
---|
|
info |
The anchor range text and numeric values for data collection needs to be populated in SUPPQS as follows. The example provided illustrates the potential response options for QSTESTCD = "QSUB0101" only, but this applies to all QSTESTCD. The standard terminology for QNAM and QLABEL are listed below. Dataset wrapdataset2 |
---|
| STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
---|
STUDYX | QS | 2324-P0001 | QSTESTCD | QSUB0106QSUB0101 | QSANTXLO | Anchor Text Low | Strongly Disagree | CRF | STUDYX | QS | 2324-P0001 | QSTESTCD | QSUB0110QSUB0101 | QSANTXHI | Anchor Text High | Strongly Agree | CRF | STUDYX | QS | 2324-P0001 | QSTESTCD | QSUB0106QSUB0101 | QSANVLLO | Anchor Numeric Value Low | 0 | CRF | STUDYX | QS | 2324-P0001 | QSTESTCD | QSUB0110QSUB0101 | QSANVLHI | Anchor Numeric Value High | 100 | CRF |
|
|
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"
QSORRES | QSSTRESC | QSSTRESN |
---|
Strongly Disagree | 0 | 0 |
10 | 10 | 10 |
20 | 20 | 20 |
30 | 30 | 30 |
40 | 40 | 40 |
50 | 50 | 50 |
60 | 60 | 60 |
70 | 70 | 70 |
80 | 80 | 80 |
90 | 90 | 90 |
Strongly Agree | 100 | 100 |
5 Supplemental Qualifier Name Codes
...