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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 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 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.

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