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  1. The original scores include a numeric rating (0-4) and a definition of what is represented by the rating (e.g., 0 = "None"). For the MTWS-R, 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. The time period of evaluation for the MTWS-R is populated in the QSEVLINTfield in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the MTWS-R is typically the last 24 hours (QSEVLINT = "-PT24H"). 

  3. 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 the derived score generation process, records are not included for scores that are not provided.

  4. The MTWS-R instrument may include an overall score that is considered as captured data on the instrument and is not considered as derived in the example below. This overall score, or total withdrawal discomfort score, consists of the first eight symptoms (i.e., QSTESTCDs MTWSR101 through MTWSR108). This score may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from http://www.med.uvm.edu/behaviorandhealth/research/minnesota-tobacco-withdrawal-scale.

    1. The overall score is represented in QSORRES, QSSTRESC, and QSSTRESN.
    2. If the overall score is received or derived by the sponsor, it is recommended that it is 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.

  5. 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 result fields is provided in Section 4, SDTM Mapping Strategy.

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