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Date

Version

Summary of Changes

20132020-1006-1815

12.0

Kurtzke Functional Systems Scores (KFSS) Draft

2013-11-13

1.0

Kurtzke Functional Systems Scores (KFSS)

  • Converted from Questionnaires (QS) domain to Disease Response and Clin Classification (RS) 
  • The RSEVAL assumption and variable was removed from this supplement, since it is not captured on the CRF and no assumptions are made on the potential values.

2014-02-19

1.1

Kurtzke Functional Systems Scores (KFSS) Revised

  • Added “Other Functions” category to the CRF, resulting in two additional QSTESTCDs (KFSS108 and KFSS108A).
  • Added Assumption 4 specifying how to record responses to KFSS108A.
  • Modified wording of answer choices on CRF to match wording in reference article.
  • Modified Assumptions 1 and 3 to reflect the updated CRF.
20202013-0611-151321.0

Converted from Questionnaires (QS) domain to Disease Response and Clin Classification (RS) 

.....copy from Hamilton 17 .... EVAL ...3rd bullet

......change the sorting from 2.0 to 1.0 top down		Kurtzke Functional Systems Scores (KFSS)
2013-10-181.0Kurtzke Functional Systems Scores (KFSS) Draft


© 2020 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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Reference for the Kurtzke Functional System Scores (KFSS)

Info

This is an example only.  Use the reference from the CDISC definition of the --CAT.

  • do not include the parentheses.
  • do not include copyright information from the definition about copyright holder and version since that's already included above.
  • do add a period to the end. 

If there are multiple references, please use the following format:

References for the Title:

  • CDISC Controlled Terminology reference.
  • additional reference.

...

Notes on the use of quotation marks:

...

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



3 The RS Domain Model

3.1 Assumptions for the RS Domain Model

...

  1. For each functional system of the KFSS, the scale points include a numeric rating (e.g. “0”) and a description of what is represented by the rating (e.g. “Normal”) with the exception of the “Unknown” option, which does not have a numeric rating.   RSORRES is populated with the rating description.  For the options with a numeric rating, RSSTRESC and RSSTRESN are populated with the numeric rating.  Otherwise, RSSTRESC is populated with the rating description and RSSTRESN is left blank.
  2. For item KFSS104, one of the rating definitions is longer than the 200 character limit imposed by SAS v5 transport files.  The QRS sub-team has paraphrased the text to shorten the responses.  The original and modified values are summarized in Section 5.
  3. Items KFSS102A and KFSS106A have the instruction “check here” when the subject has the specified condition (weakness, temporal pallor).  RSORRES and RSSTRESC = “CHECKED” or “NOT CHECKED”.  RSSTRESN is always left blank.
  4. Item KFSS108A will only be answered if KFSS108 has RSORRES = “Any other neurologic findings attributed to MS (specify)”.  If KFSS108A is not answered, do not create a record in SDTM for it.
  5. Terminology:
    1. RSCAT, RSTESTCD and RSTEST are approved CDISC controlled terminology.
    2. A full list of value sets for qualifier and result fields is provided in Section 4: SDTM Mapping Strategy.

  1. Terminology

    1. RSCAT, RSTESTCD, and 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. 

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

...

Row

RSBLFL

VISITNUM

RSDTC

1 (cont)

Y

1

2012-11-16

2 (cont)

Y

1

2012-11-16

3 (cont)

Y

1

2012-11-16

4 (cont)

Y

1

2012-11-16

5 (cont)

Y

1

2012-11-16

...

The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes):

Text that would remain unchanged has been left in black:

The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.




4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, and RSSTRESN) should be populated.

RSTESTCD = "KFSS101" RSTEST = "KFSS1-Pyramidal Functions "

RSORRES

RSSTRESC

RSSTRESN

Normal00
Abnormal signs without disability11
Minimal disability22
Mild or moderate paraparesis or hemiparesis; severe monoparesis33
Marked paraparesis or hemiparesis; moderate quadriparesis; or monoplegia44
Paraplegia, hemiplegia, or marked quadriparesis55
Quadriplegia66
UnknownUnknown


RSTESTCD = "KFSS102" RSTEST = "KFSS1-Cerebellar Functions"

RSORRES

RSSTRESC

RSSTRESN

Normal00
Abnormal signs without disability11
Mild ataxia22
Moderate truncal or limb ataxia33
Severe ataxia, all limbs44
Unable to perform coordinated movements due to ataxia55
UnknownUnknown


RSTESTCD = "KFSS102A" RSTEST = "KFSS1-Weakness Interferes With Testing"

RSTESTCD = "KFSS106A" RSTEST = "KFSS1-Presence of Temporal Pallor"

RSORRES

RSSTRESC

CHECKEDCHECKED
NOT CHECKEDNOT CHECKED


RSTESTCD = "KFSS103" RSTEST = "KFSS1-Brain Stem Functions"

RSORRES

RSSTRESC

RSSTRESN

Normal00
Signs only11
Moderate nystagmus or other mild disability22
Severe nystagmus, marked extraocular weakness, or moderate disability of other cranial nerves33
Marked dysarthria or other marked disability44
Inability to swallow or speak55
UnknownUnknown


RSTESTCD = "KFSS104" RSTEST = "KFSS1-Sensory Functions"

RSORRES

RSSTRESC

RSSTRESN

Normal00
Vibration or figure-writing decrease only, in one or two limbs11
Mild decrease in touch or pain or position sense, and/or moderate decrease in vibration in one or two limbs; or vibratory (c/s figure writing) decrease alone in three or four limbs22
Moderate decrease in touch or pain or position sense, and/or lost vibration in 1 or 2 limbs; or mild decrease in touch or pain and/or moderate decrease in all proprioceptive tests in 3 or 4 limbs33
Marked decrease in touch or pain or loss of proprioception, alone or combined, in one or two limbs; or moderate decrease in touch or pain and/or severe proprioceptive decrease in more than two limbs44
Loss (essentially) of sensation in one or two limbs; or moderate decrease in touch or pain and/or loss of proprioception for most of the body below the head55
Sensation essentially lost below the head66
UnknownUnknown


RSTESTCD = "KFSS105" RSTEST = "KFSS1-Bowel and Bladder Functions"

RSORRES

RSSTRESC

RSSTRESN

Normal00
Mild urinary hesitancy, urgency, or retention11
Moderate hesitancy, urgency, retention of bowel or bladder, or rare urinary incontinence22
Frequent urinary incontinence33
In need of almost constant catheterization44
Loss of bladder function55
Loss of bowel and bladder function66
UnknownUnknown


RSTESTCD = "KFSS106" RSTEST = "KFSS1-Visual or Optic Functions"

RSORRES

RSSTRESC

RSSTRESN

Normal00
Scotoma with visual acuity (corrected) better than 20/3011
Worse eye with scotoma with maximal visual acuity (corrected) of 20/30 to 20/5922
Worse eye with large scotoma, or moderate decrease in fields, but with maximal visual acuity (corrected) of 20/60 to 20/9933
Worse eye with marked decrease of fields and maximal visual acuity (corrected) of 20/100 to 20/200; grade 3 plus maximal acuity of better eye of 20/60 or less44
Worse eye with maximal visual acuity (corrected) less than 20/200; grade 4 plus maximal acuity of better eye of 20/60 or less55
Grade 5 plus maximal visual acuity of better eye of 20/60 or less66
UnknownUnknown


RSTESTCD = "KFSS107" RSTEST = "KFSS1-Cerebral or Mental Functions"

RSORRES

RSSTRESC

RSSTRESN

Normal00
Mood alteration only (does not affect DSS score)11
Mild decrease in mentation22
Moderate decrease in mentation33
Marked decrease in mentation (chronic brain syndrome – moderate)44
Dementia or chronic brain syndrome – severe or incompetent55
UnknownUnknown


RSTESTCD = "KFSS108" RSTEST = "KFSS1-Other Functions"

RSORRES

--STRESC

--STRESN

None00
Any other neurologic findings attributed to MS (specify)11
UnknownUnknown

...

Namesuppqs

...

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, and RSSTRESN) should be populated.

Do I copy from the legacy document or from QRS maker?

what should be done for section 5?  the legacy document has a table.

5 Supplemental Qualifier Name Codes

Info

The instrument used as an example in this template did not require supplemental qualifiers, but this section has been included to provide guidance on those instruments which do require supplemental qualifiers. (Many instruments do not require it.) Text that always will be in the section when it is included has been left black.

Additional rows will be required in the suppqs.xpt dataset for each supplemental qualifier needed.

Remove Section 5 if it does not apply to the new instrument.

The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires (SUPPQS) special purpose dataset.

...

Namesuppqs

...


End of Document