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© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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1. Include a description of scale score or other possible responses (You may need multiple numbered points for this, though the IDS-SR did not.). For scale scores use the following language: 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. The RSREPNUM variable is used to indicate the same RSTESTSs are used in trial 1, 2, 3, and 4.

3. 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 score generation processes, records are not included for derived subscores or total scores that are not provided.

4. 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. 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:

   When assigned with conditionally branched responses are not documented in the instrument’s instructions or a user manual:

   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).

   When assigned conditionally branched responses are documented in instructions or a user manual:

   1. QNAM = “QSCBRFL”, QLABEL = “Conditional Branched Item Flag“, QVAL = “Y” (this is a QS supplemental qualifier variable).
   2. The QSORRES responses are represented as follows:
   1. For severity items, QSORRES = "None".
   2. For interference items, QSORRES = "Not at all".
   3. If numeric response values are assigned, they are represented here: QSSTRESC = 0 and QSSTRESN = 0.

      or if no numeric responses are assigned: QSSTRESC = NULL and QSSTRESN = NULL.

5. 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.  The SDS RS Team is researching alternative methods to handle this data in the future, but until a new method is identified, this will be the recommended approach.
   The 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.
   

   
   

6. For the NRS question (RSTESTCD=CBS0109), RSMETHOD is populated with “NUMERICAL RATING SCALE 11-POINT”.
7. The RSREPNUM variable is used to indicate the same RSTESTSs are used in trial 1, 2, 3, and 4.

8. 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.

9. 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. 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).

   
   

10. Include this point if score(s) are submitted to SDTM. Update blue text: 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 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.]. Monique van Dijk en Erwin Ista.

    1. Subscores and overall Subtotal and total scoresare 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.

11. Terminology

    1. RSCAT, RSTESTCD, RSTEST 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.)

3.2 Example for the COMFORT-B SCALE RS Domain Model

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