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1. The scale points include a numeric rating (1-5) and a definition of what is represented by the rating (e.g., 1 = "deeply asleep (eyes closed, no response to changes in the environment)"). For the COMFORT-B SCALE, RSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN. 

2. Visual analog or numeric rating scales used within a questionnaire with a range of text and numeric values are indicated in the SUPPRS domain with:

   QNAM="RSANTXLO"     QNAM="RSANTXHI"

   QNAM="RSANVLLO"     QNAM="RSANVLHI"
   By storing this information in SUPPRS, it is available for interpretation purposes.
   When the value of the data being represented equals a low or high anchor value, the corresponding low and high anchor text is stored in RSORRES with the numeric values stored in RSSTRESC and RSSTRESN.  All other numeric values are stored in RSORRES, RSSTRESC and RSSTRESN.
   

   
   

3. RSMETHOD is populated with "NUMERICAL RATING SCALE 11-POINT" when RSTESTCD="CBS0109". The NRS is a global pain rating scale (0 ="no pain" and 10 ="worst imaginable pain"). 
4. In addition of the NRS, the level of sedation (NISS="Nurse Interpretation of Sedation Score") is categorized as 1="insufficient sedation", 2="adequate sedation" and 3="oversedation".
5. The RSREPNUM variable is used to indicate the same RSTESTSs are used in trial 1, 2, 3, and 4.

6. Records are created in rs.xpt for every instrument item: 

   1. For items with no data, RSORRES, RSSTRESC, and RSSTRESN are all missing and RSSTAT = "NOT DONE". If the reason is known then that reason is represented in RSREASND (e.g., RSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then RSSTAT = "NOT DONE" and RSREASND 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.

7. Some items on the COMFORT-B SCALE may be conditionally branched per the instrument instructions. Only Respiratory Ventilation or Crying (RSTESTCD = "CBS0103" or "CBS0104") is completed for each subject.

   Jira
   showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-759

   The other will be treated as a conditionally branched item. A record is created in rs.xpt for all items. When an item is considered a conditionally branched item, it is represented as follows:
   1. QNAM = “RSCBRFL”, QLABEL = “Conditional Branched Item Flag“, QVAL = “Y” (this is a RS supplemental qualifier variable related to the record).
   2. RSORRES, RSSTRESC, and RSSTRESN are set to null (missing).

   
   

8. The COMFORT-B SCALE instrument includes a total score that is 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 Monique van Dijk en Erwin Ista.

   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 responsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.

9. Terminology

   1. RSCAT, RSTESTCD, RSTEST 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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