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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 past 24 hours (QSEVLINT = "-P24H"). 

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 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.

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. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from [Insert copyright holder's name or other source.].

   1. Subscores and overall scores are represented in --ORRES, --STRESCQSORRES, QSSTRESC, and --STRESNQSSTRESN.
   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.
      

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.

3.2 Example for the

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MTWS-R QS Domain Model

The QRS Short_Name  MTWS-R 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_Namethe MTWS-R 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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The table represents the items from the QRS Short_Name MTWS-R instrument.

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