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• 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. It consists of 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.

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.

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 numeric values stored in QSSTRESC and QSSTRESN.  All other numeric values are stored in QSORRES, QSSTRESC and QSSTRESN.
3. Items are divided into 2 subcategories represented in QSSCAT: "FACTOR 1", and "FACTOR 2". (Note: Remove this if 3.1.6 is applicable. If this remains include QSSCAT in 3.1.7 and 3.2)
4. 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").
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

6. The original scores include a numeric rating (0-100) in increments of 10, and a definition of what the ratings represent at the scale extremes (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. 

7. 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 numeric values stored in QSSTRESC and QSSTRESN.  All other numeric values are stored in QSORRES, QSSTRESC and QSSTRESN.
8. 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").
9. 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.

10. Include this point if overall score(s) are submitted to SDTM. Update blue text: The QRS Short_Name instrument includes an overall score (and subscores or other scores as needed.  If so, change "that is" to "that are") that is considered 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 These scores may be submitted in SDTM or derived in the Analysis the Analysis Data Model (ADaM)  per per scoring instructions from [Insert copyright holder's name or other source.] 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.
    Please review the decision on not including –EVAL and --EVALID in the QRS Supplement Best Practices topic “--EVAL/–EVALID not included in QRS domains/datasets”.Now we only represent administrative information if it is explicitly collected on an instrument. No assumptions are made for this data; if it's not on the instrument, it's not in the data.

    The SUPPQUAL variables used are a series of non-standard variables that represent collected administrator information, administration device, etc., and these updated SUPPQUAL variables are included in the WIKI non-standard variable registry (Non-standard Variable Registry). For example:

    1. PPRAID which is "Preprinted Administrator Identifier".
    2. COLAVL which is "Collected Administrator Value".

    The supplement version 1.0 of the FAS-NACC UDS V3.0 instrument shows an implementation example.

    The QRS Short_Name instrument collects administrative information as the preprinted examiner’s initials and the collected response. This is represented in the SUPPQUAL variable QNAM = --PPRAID” with QNAM = “Preprinted Administrator Identifier” and QVAL = “EXAMINER’S INITIALS”. The collected initials response is represented with QNAM = “--COLAID” and QNAM = “Collected Administrator Identifier” and QVAL = “ADM1”.

    This is part of the data example for the SUPPQUAL variables.

    The SUPPRS table represents the preprinted and collected administrative items represented on the CRF. 

     supprs.xpt

    STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
    STUDYX	RS	100-10001	RSCAT	FAS-NACC UDS V3.0	RSPPRAID	Preprinted Administrator Identifier	EXAMINER'S INITIALS	CRF
    STUDYX	RS	100-10001	RSCAT	FAS-NACC UDS V3.0	RSCOLAID	Collected Administrator Identifier	ADM1	CRF

11. Include this point if there are comments at the end of the instrument. Remove this point if it does not apply.: Comments located at the end of the QRS Short_Name will be recorded in the Comments domain (CO). All assumptions and business rules described in the SDTMIG CO domain are applicable.

12. Include this point if there are responses over 200 characters. Remove this point if it does not apply: Some responses to the QRS Short_Name items exceeded the 200-character limit for the QSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which item responses were revised in order to fit the 200-character limit
    1. 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.

13. Terminology

    1. QSCAT, QSTESTCD, QSTEST, QSORRES, QSSTRESC, and QSSTRESN (and other variables such as QSORRESU as needed; only include QSORRES, QSSTRESC, and QSSTRESN if the responses are published in CT with public domains instruments)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.)

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3.2 Example for the QRS

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QSU-BRIEF QS Domain Model

The QRS Short_Name  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 Short_Name 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. When there are numeric results, then use this sentence next, "This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC." When the results are character only, then use these sentences next, "This result is then transformed into the standard character representation in QSSTRESC. QSSTRESN is null as there are no standardized numeric results for this instrument."

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