Page History
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Revision History
Date | Version | Summary of Changes |
2023- |
09- |
07 | 2. |
- 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.
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1 Revision Draft |
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2021-04-03 | 2.0 |
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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) |
© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
1 Introduction
This document describes the CDISC implementation of the Kurtzke Functional System Scores (KFSS) instrument.
CDISC did not modify this questionnaires, ratings, and scales (QRS) instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.
The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which
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1 Introduction
This document describes the CDISC implementation of the Kurtzke Functional System Scores (KFSS) instrument.
CDISC does not modify questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.
The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.
These specific implementation details for this clinical classification 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.
The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/aboutstandards/foundational/bylawssdtmig.
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These specific implementation details for this 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.
The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.
1.1 Representations and Warranties, Limitations of Liability, and Disclaimers
This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.
CDISC specifies how to structure the data that data that has been collected in a database, not what should be collected or how to conduct clinical assessments or implement protocols. CDISC disclaims any liability for your use of this material.
2 Copyright Status
This instrument is in the public domainCDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the Kurtzke Functional System Scores (KFSS) in KFSS in the CDISC library of QRS data standards supplements. Hence Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the clinical classificationthe 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.
The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with example(s), and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values.
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The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF. |
Note: CDISC Controlled Terminology is 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/controlled-terminology.
Reference for the Kurtzke Functional System Scores ( KFSS):
- Kurtzke JF. Rating Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52.
3 The
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RS Domain Model
3.1 Assumptions for the
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RS Domain Model
All assumptions and business rules described in the SDTMIG RS domain RS domain are applicable to this supplement. Additional assumptions specific to the Kurtzke Functional System Scores (KFSS) are the KFSS are listed below.
Kurtzke Functional Systems Scores (KFSS): The KFSS consists of 7 functional systems (plus “other”) with an ordinal clinical rating scale for each . functional system in either a 7-point, 6-point, or 2-point scale. 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.
The Kurtzke Functional Systems Scores (KFSS) and Kurtzke Expanded Disability Status Scale (EDSS) instruments are intended to be used in conjunction with one another. The KFSS should first be administered by the evaluator; results from this assessment are then applied to determine an EDSS overall score (Kurtzke, 1983). A change in the EDSS should only occur if there has been a change in 1 or more Functional System (FS) scores. Please review the published Kurtzke Expanded Disability Status Scale (EDSS) for details on the related EDSS overall score.
- For each functional system of the KFSS, the original scores 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. 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.
- 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 (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.
- Item KFSS108A will only be answered if KFSS108 has RSORRES = “Any other neurologic findings
When RSTESTCD = "KFSS108" is not answered, the result is considered a not done record with RSORRES/RSSTRESC/RSSTRESN represented as missing values and RSSTAT = "NOT DONE”. Item RSTESTCD = "KFSS108A" will only be answered if RSTESTCD = "KFSS108" has a 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.
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, otherwise it will be considered a not done record with RSORRES/RSSTRESC/RSSTRESN represented as missing values and RSSTAT = "NOT DONE”.
- 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.
- 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
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System Scores (KFSS) Domain Model
The Kurtzke Functional System Scores ( KFSS ) example below shows the terminology used to implement the instrument in the RS RS domain. This This example shows the data for one 1 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 pallorand a visit 2 represented as not being collected for the KFSS instrument. The example uses CDISC controlled terminology Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. RSBLFL is Y based on VISITNUM=1. All original results, matching the CRF item response text, are represented with preferred terminology in RSORRES. Typically, this This result is then transformed into represented as a standard numeric score in RSSTRESN and in RSSTRESN and as a standard 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.
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in RSSTRESC. Character only responses, such as "Unknown" are represented in RSORRES and RSSTRESC and RSSTRESN is null as there are no standardized numeric result.
The table represents the items from the KFSS instrument.
| Dataset wrap | ||
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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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...
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...
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...
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Severe ataxia, all limbs
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4
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4
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...
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...
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...
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...
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...
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STUDYX
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RS
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P0001
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5
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10
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STUDYX
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rs.xpt (cont)
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Row
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RSBLFL
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RSDTC
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1 (cont)
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2 (cont)
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Y
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1
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2012-11-16
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2012-11-16
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4 (cont)
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Y
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1
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2012-11-16
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5 (cont)
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Y
...
1
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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 "
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RSORRES
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RSSTRESC
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RSSTRESN
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RSTESTCD = "KFSS102" RSTEST = "KFSS1-Cerebellar Functions"
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RSORRES
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RSSTRESC
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RSSTRESN
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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
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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
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RSSTRESC
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RSTESTCD = "KFSS103" RSTEST = "KFSS1-Brain Stem Functions"
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RSORRES
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RSSTRESC
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RSSTRESN
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RSTESTCD = "KFSS104" RSTEST = "KFSS1-Sensory Functions"
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RSORRES
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RSSTRESC
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RSSTRESN
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RSTESTCD = "KFSS105" RSTEST = "KFSS1-Bowel and Bladder Functions"
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RSORRES
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RSSTRESC
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RSSTRESN
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RSTESTCD = "KFSS106" RSTEST = "KFSS1-Visual or Optic Functions"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| Normal | 0 | 0 |
| 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 = "KFSS107KFSS105" RSTEST = "KFSS1-Cerebral or Mental Bowel and Bladder Functions"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| Normal | 0 | 0 |
| Mild urinary hesitancy, urgency, or retention | 1 | 1 |
| Moderate hesitancy, urgency, retention of bowel or bladder, or rare urinary incontinence | 2 | 2 |
| Frequent urinary incontinence | 3 | 3 |
| In need of almost constant catheterization | 4 | 4 |
| Loss of bladder function | 5 | 5 |
| Loss of bowel and bladder function | 6 | 6 |
| Unknown | Unknown |
RSTESTCD = "KFSS108KFSS106" RSTEST = "KFSS1-Other Visual or Optic Functions"
RSORRES | RSSTRESC | RSSTRESN |
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| Normal | 0 | 0 |
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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| 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 = "KFSS107" RSTEST = "KFSS1-Cerebral or Mental Functions"
RSORRES | RSSTRESC | RSSTRESN |
|---|---|---|
| Normal | 0 | 0 |
| Mood alteration only (does not affect DSS score) | 1 | 1 |
| Mild decrease in mentation | 2 | 2 |
| Moderate decrease in mentation | 3 | 3 |
| Marked decrease in mentation (chronic brain syndrome – moderate) | 4 | 4 |
| Dementia or chronic brain syndrome – severe or incompetent | 5 | 5 |
| Unknown | Unknown |
RSTESTCD = "KFSS108" RSTEST = "KFSS1-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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