Page History
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Date | Version | Summary of Changes | ||
2020-06-1530 | 2.0 |
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2014-02-19 | 1.1 | 2014-02-19 | 1.1 | Kurtzke Functional Systems Scores (KFSS) Revised
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| 2013-11-13 | 1.0 | Kurtzke Functional Systems Scores (KFSS) | ||
| 2013-10-18 | 1.0 | Kurtzke Functional Systems Scores (KFSS) Draft |
© 2020 Clinical Data Interchange Standards Consortium© 2020 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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These specific implementation details for this clinical classification instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/foundational/qrs.
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CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols.
2 Copyright Status
This instrument CDISC believes this instrument is in the public domain. CDISC has included the Kurtzke Functional System Scores (KFSS) in the CDISC library of QRS data standards supplements. Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the clinical classification instrument. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.
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Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology.
Reference for the Kurtzke Functional System Scores (KFSS):
- 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
All assumptions and business rules described in the SDTMIG RS domain are applicable to this supplement. Additional assumptions specific to the Kurtzke Functional System Scores (KFSS) are listed below.
Kurtzke Functional Systems Scores (KFSS): The KFSS consists The KFSS consists of 7 functional systems (plus “other”) with an ordinal clinical rating scale for each. The functional systems included in the KFSS are the pyramidal, cerebellar, brain stem, sensory, bowel/bladder, visual, cerebral, and other functions. In addition to the functional system rating scales, there are 2 additional questions asking about weakness and temporal pallor, which could affect the ratings.
- For each functional system of the KFSS, the the scale points include a numeric rating (e.g. “0”) and a description 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. RSORRES is populated with the rating description. For the options with KFSS, for functional systems with a numeric rating, RSSTRESC and RSSTRESN are RSORRES is populated with the text description while the numeric rating . Otherwise, RSSTRESC is populated with the 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.
- 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.
- 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.
- 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.
- Terminology:
- RSCAT, RSTESTCD and RSTEST are approved CDISC controlled terminology.
- A full list of value sets for qualifier and result fields is provided in Section 4: SDTM Mapping Strategy.
3.2 Example for the Kurtzke Functional System Scores (KFSS) Domain Model
The Kurtzke Functional System Scores (KFSS) example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for one subject collected at the baseline visit for a KFSS questionnaire. The subject did not experience weakness that interfered with the testing, but did have temporal pallor. The example uses CDISC controlled terminology for RSTESTCD, RSTEST, and RSCAT. RSBLFL is Y based on VISITNUM=1. All original results are represented with preferred terminology in RSORRES. Typically, this result is then transformed into a standard numeric score in RSSTRESN and a character representation of the standard numeric score in RSSTRESC.
Rows 1-10: Shows the questions from the KFSS form. Note that a record for RSTESTCD=KFSS108A is not shown since RSORRES=“None” 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.
rs.xpt
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Row
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STUDYID
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DOMAIN
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USUBJID
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RSSEQ
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RSTESTCD
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RSTEST
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RSCAT
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RSORRES
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RSSTRESC
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RSSTRESN
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1
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STUDYX
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RS
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P0001
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1
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KFSS101
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KFSS1-Pyramidal Functions
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KFSS
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Minimal disability
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2
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2
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2
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STUDYX
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RS
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P0001
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2
...
KFSS102
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KFSS1-Cerebellar Functions
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KFSS
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Severe ataxia, all limbs
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4
...
4
...
3
...
STUDYX
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RS
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P0001
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3
...
KFSS102A
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KFSS1-Weakness Interferes With Testing
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KFSS
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NOT CHECKED
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NOT CHECKED
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...
4
...
STUDYX
...
RS
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P0001
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4
...
KFSS103
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KFSS1-Brain Stem Functions
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KFSS
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Normal
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0
...
0
...
5
...
STUDYX
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RS
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P0001
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5
...
KFSS104
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KFSS1-Sensory Functions
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KFSS
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Vibration or figure-writing decrease only, in one or two limbs
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1
...
1
...
6
...
STUDYX
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RS
...
P0001
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6
...
KFSS105
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KFSS1-Bowel and Bladder Functions
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KFSS
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Frequent urinary incontinence
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3
...
3
...
7
...
STUDYX
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RS
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P0001
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7
...
KFSS106
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KFSS1-Visual or Optic Functions
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KFSS
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Grade 5 plus maximal visual acuity of better eye of 20/60 or less
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6
...
6
...
8
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STUDYX
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RS
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P0001
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8
...
KFSS106A
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KFSS1-Presence of Temporal Pallor
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KFSS
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CHECKED
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CHECKED
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...
9
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STUDYX
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RS
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P0001
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9
...
KFSS107
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KFSS1-Cerebral or Mental Functions
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KFSS
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Unknown
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Unknown
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...
10
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STUDYX
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RS
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P0001
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10
...
KFSS108
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KFSS1-Other Functions
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KFSS
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None
...
0
...
0
- 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.
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.- 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.
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.
- Terminology:
- RSCAT, RSTESTCD and RSTEST are approved CDISC controlled terminology.
- 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 one subject collected at the baseline visit for a KFSS instrument. The example uses CDISC controlled terminology for RSTESTCD, RSTEST, and RSCAT. RSLOBXLFL is Y based on VISITNUM=1. All original results are represented with preferred terminology in RSORRES. Typically, this result is then transformed into a standard numeric score in RSSTRESN and a character representation of the standard numeric score in RSSTRESC.
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 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 record for RSTESTCD=KFSS108A is not shown since RSORRES=“None” 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.
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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 |
|---|---|---|
| Normal | 0 | 0 |
| Abnormal signs without disability | 1 | 1 |
| Minimal disability | 2 | 2 |
| Mild or moderate paraparesis or hemiparesis; severe monoparesis | 3 | 3 |
| Marked paraparesis or hemiparesis; moderate quadriparesis; or monoplegia | 4 | 4 |
| Paraplegia, hemiplegia, or marked quadriparesis | 5 | 5 |
| Quadriplegia | 6 | 6 |
| Unknown | Unknown |
RSTESTCD = "KFSS102" RSTEST = "KFSS1-Cerebellar Functions"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| Normal | 0 | 0 |
| Abnormal signs without disability | 1 | 1 |
| Mild ataxia | 2 | 2 |
| Moderate truncal or limb ataxia | 3 | 3 |
| Severe ataxia, all limbs | 4 | 4 |
| Unable to perform coordinated movements due to ataxia | 5 | 5 |
| Unknown | Unknown |
RSTESTCD = "KFSS102A" RSTEST = "KFSS1-Weakness Interferes With Testing"
RSTESTCD = "KFSS106A" RSTEST = "KFSS1-Presence of Temporal Pallor"
RSORRES | RSSTRESC |
|---|---|
| CHECKED | CHECKED |
| NOT CHECKED | NOT CHECKED |
RSTESTCD = "KFSS103" RSTEST = "KFSS1-Brain Stem Functions"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| Normal | 0 | 0 |
| Signs only | 1 | 1 |
| Moderate nystagmus or other mild disability | 2 | 2 |
| Severe nystagmus, marked extraocular weakness, or moderate disability of other cranial nerves | 3 | 3 |
| Marked dysarthria or other marked disability | 4 | 4 |
| Inability to swallow or speak | 5 | 5 |
| Unknown | Unknown |
RSTESTCD = "KFSS104" RSTEST = "KFSS1-Sensory Functions
rs.xpt (cont)
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Row
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RSBLFL
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VISITNUM
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RSDTC
...
1 (cont)
...
Y
...
1
...
2012-11-16
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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
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 |
|---|---|---|
| Normal | 0 | 0 |
RSTESTCD = "KFSS102" RSTEST = "KFSS1-Cerebellar Functions"
...
RSORRES
...
RSSTRESC
...
RSSTRESN
| Vibration or figure-writing decrease only, in one or two limbs | 1 | 1 |
| 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 limbs | 2 | 2 |
| 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 limbs | 3 | 3 |
| 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 limbs | 4 | 4 |
| 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 head | 5 | 5 |
| Sensation essentially lost below the head | 6 | 6 |
| Unknown | Unknown |
RSTESTCD = "KFSS105" RSTEST = "KFSS1-Bowel and Bladder
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RSTESTCD = "KFSS102A" RSTEST = "KFSS1-Weakness Interferes With Testing"
RSTESTCD = "KFSS106A" RSTEST = "KFSS1-Presence of Temporal Pallor"
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RSORRES
...
RSSTRESC
...
RSTESTCD = "KFSS103" RSTEST = "KFSS1-Brain Stem Functions"
RSORRES | RSSTRESC | RSSTRESN | |||
|---|---|---|---|---|---|
| Normal | 0 | 0Signs only | |||
| Mild urinary hesitancy, urgency, or retention | 1 | 1 | |||
| Moderate nystagmus or other mild disability | 2 | 2 | hesitancy, urgency, retention of bowel or bladder, or rare urinary incontinence | 2 | 2 |
| Frequent urinary incontinenceSevere nystagmus, marked extraocular weakness, or moderate disability of other cranial nerves | 3 | 3Marked dysarthria or other marked disability | |||
| In need of almost constant catheterization | 4 | 4Inability to swallow or speak | |||
| Loss of bladder function | 5 | 5 | |||
| Loss of bowel and bladder function | 6 | 6 | |||
| Unknown | Unknown |
RSTESTCD = "KFSS104KFSS106" RSTEST = "KFSS1-Sensory Visual or Optic Functions"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| Normal | 0 | 0 |
| Scotoma with visual acuity (corrected) better than 20/30 | 1 | 1 |
| Worse eye with scotoma with maximal visual acuity (corrected) of 20/30 to 20/59 | 2 | 2 |
| Worse eye with large scotoma, or moderate decrease in |
| fields, but with maximal visual acuity (corrected) of 20/60 to 20/99 | 3 | 3 |
| 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 less | 4 | 4 |
| Worse eye with maximal visual acuity (corrected) less than 20/200; grade 4 plus maximal acuity of better eye of 20/60 or less | 5 | 5 |
| Grade 5 plus maximal visual acuity of better eye of 20/60 or less | 6 | 6 |
| Unknown | Unknown |
RSTESTCD = "KFSS105KFSS107" RSTEST = "KFSS1-Bowel and Bladder Cerebral or Mental Functions"
RSORRES | RSSTRESC | RSSTRESN | |
|---|---|---|---|
| Normal | 0 | 0Mild urinary hesitancy, urgency, or retention | |
| Mood alteration only (does not affect DSS score) | 1 | 1Moderate hesitancy, urgency, retention of bowel or bladder, or rare urinary incontinence | |
| Mild decrease in mentation | 2 | 2Frequent urinary incontinence | |
| Moderate decrease in mentation | 3 | 3In need of almost constant catheterization | |
| Marked decrease in mentation (chronic brain syndrome – moderate) | 4 | 4 | |
| Dementia or chronic brain syndrome – severe or incompetent | Loss of bladder function | 5 | 5 |
| Loss of bowel and bladder function | 6 | 6 | |
| Unknown | Unknown |
RSTESTCD = "KFSS106KFSS108" RSTEST = "KFSS1-Visual or Optic Functions"
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RSORRES
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RSSTRESC
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RSSTRESN
...
RSTESTCD = "KFSS107" RSTEST = "KFSS1-Cerebral or Mental Functions"
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RSORRES
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RSSTRESC
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RSSTRESN
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RSTESTCD = "KFSS108" RSTEST = "KFSS1-Other Functions"
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RSORRES
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RSSTRESC
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RSSTRESN
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5 Original and RSORRES Comparison - RSTESTCD=KFSS104
???? SHOULD I MAKE THE TABLE IN QRS Maker????? or just copy from the version 1.1 word file??
??Should I make section 5 or just add the comparison table?
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Other Functions"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| None | 0 | 0 |
| Any other neurologic findings attributed to MS (specify) | 1 | 1 |
| Unknown | Unknown |
Original and RSORRES Comparison - RSTESTCD=KFSS104
RSSTRESN | KFSS1-Sensory Functions (Original) | RSORRES Value |
0 | Normal | Normal |
1 | Vibration or figure-writing decrease only, in one or two limbs | Vibration or figure-writing decrease only, in one or two limbs |
2 | 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 limbs | 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 limbs |
3 | Moderate decrease in touch or pain or position sense, and/or essentially lost vibration in one or two limbs; or mild decrease in touch or pain and/or moderate decrease in all proprioceptive tests in three or four limbs | 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 limbs |
4 | 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 limbs | 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 limbs |
5 | 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 head | 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 head |
6 | Sensation essentially lost below the head | Sensation essentially lost below the head |
| Unknown | Unknown |
End of Document
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