...

...

...

Reference for the KFSS:

• Kurtzke JF.  Rating  Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52.
  

...

1. For each functional system of the KFSS, the scale points include a numeric rating and a definition of what is represented by the rating (e.g., 0 = “Normal”) with the exception of the “Unknown” option, which does not have a numeric rating. For the KFSS, for functional systems with a numeric rating, RSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN. Otherwise, RSSTRESC is populated with the rating description and RSSTRESN is left blank.

2. Some responses to the KFSS items exceeded the 200-character limit for the RSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which item responses were revised in order to fit the 200-character limit. For item KFSS104, one of the rating responses is longer than the 200 character limit.

3. Some items on the KFSS may be logically skipped per the instrument instructions. Responses for logically skipped items should be (1) recorded and/or scored according to the instructions provided in the instrument’s user manual, scoring manual, or other documentation provided by the instrument developer and (2) included in the submission dataset. If such instructions are not available, then records for logically skipped items should be included in the submission dataset with:
           RSSTAT = "NOT DONE";
           RSREASND = "LOGICALLY SKIPPED ITEM"; and
           RSORRES, RSSTRESC, and RSSTRESN all set to null
   When submitting data to US FDA or some other regulatory authority to support regulatory review of a medical product, if the electronic data collection system is not capable of automatically populating records for logically skipped items, these records should be post-populated prior to submission and the sponsor will need to explain this in the corresponding reviewer's guide.

   1. Item KFSS108A will only be answered if KFSS108 has RSORRES = “Any other neurologic findings attributed to MS (specify)”. If KFSS108A is not answered, it is considered a logically skipped record.

4. Items KFSS102A and KFSS106A have the instruction “check here” when the subject has the specified condition (e.g., weakness, temporal pallor). RSORRES and RSSTRESC = “CHECKED” or “NOT CHECKED”. RSSTRESN is always left blank.

5. Terminology:
   1. RSCAT, RSTESTCD and RSTEST are approved CDISC controlled terminology.
   2. A full list of value sets for result fields is provided in Section 4: SDTM Mapping Strategy.

3.2 Example for the Kurtzke Functional System Scores (KFSS) Domain Model

...

1. Items KFSS102A and KFSS106A have the instruction “check here” when the subject has the specified condition (e.g., weakness, temporal pallor). RSORRES and RSSTRESC = “CHECKED” or “NOT CHECKED”. RSSTRESN is always left blank.

2. Terminology:
   1. RSCAT, RSTESTCD and RSTEST are approved CDISC controlled terminology.
   2. A full list of value sets for result fields is provided in Section 4: SDTM Mapping Strategy.

3.2 Example for the Kurtzke Functional System Scores (KFSS) Domain Model

The KFSS example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for 1 subject collected at the baseline visit for the KFSS instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results are represented with preferred terminology in RSORRES. This result is then transformed into the standard numeric score in RSSTRESN and a character representation of the standard numeric score in of the standard numeric score in RSSTRESC. Character only responses, such as "Unknown" are represented in RSORRES and RSSTRESC.

 The table represents the items from the KFSS form. The subject did not experience weakness that interfered with the testing, but did have temporal pallor.Rows 1-10:     Shows the questions from the KFSS form. Note that a  The subject had unknown brain stem functions. A record for RSTESTCD=KFSS108A is not shown since RSORRES=“None” represented with RSSTAT = "NOT DONE" since for RSTESTCD = KFSS108 .

Rows 3 and 8 show RSORRES = “NOT CHECKED” and “CHECKED”, respectively, since the subject did not experience weakness that interfered with the testing and the subject had temporal pallor.

the RSORRES = “None”. 

4 SDTM Mapping Strategy

...