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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
Date2024-01-0304
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.

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Revision History

DateVersion
2024-01-03041.0 Draft

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

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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 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 14, 3, 6, 78, and 9, 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.

  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 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--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 qualifier, timing, resultand 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.)

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Dataset wrap
Nameqs
Rowcaps
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 6514: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.
Dataset2
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
14Rows 11-32 removed for ease of use of template. (fyi, this row has merged cells so don't try to overwrite it when using the template; just delete it.)65STUDYXQS2324-P00011QSUB0101QSUB01-Desire Cigarette Right NowQSU-BRIEF


NOT DONESUBJECT REFUSED
22015-05-15

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Info

"All QSTESTCDs"

QSORRESQSSTRESCQSSTRESN
Strongly Disagree00
101010
202020
303030
404040
505050
606060
707070
808080
909090
Strongly Agree100100
Info
titleFor public domain instrument's published QRS responses

If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses. This approach used the CDISC QRS CT instrument's SYNONYM as part of the codelist name.

The controlled response terminology for the tests below is named SYNONYMSET1OR for the variable RSORRES and SYNONYMSET1STR for the variables RSSTRESN and RSSTTRESC.

Info
titleFor public domain instrument's published QRS responses

If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses.

The controlled response terminology for the tests below is named --TESTCDTXXXOR for the variable RSORRES and --TESTCDTXXXTSTR for the variables RSSTRESN and RSSTTRESC.


5 Supplemental Qualifier Name Codes

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