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Info

We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.

The tabletables

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyQRSSUPP-483
represents the items from the EDSS instrumentthe KFSS and EDSS instruments to show their relationship.
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyQRSSUPP-389

The KFSS responses are used to determine the EDSS score.

Dataset wrap
Namersrskfss
Dataset2
Rowcaps
Rows 8, 9, 14:Represent RSORRES values that needed to be shortened in order to meet the 200-character SAS V5 transport file restriction.
Row 16:

Represents a subject (P0016)

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyQRSSUPP-391
that was not evaluated on this instrument at visit 1. Since the visit was missed, the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred

Dataset2
RowSTUDYIDDOMAINUSUBJIDRSSEQRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSSTRESNRSSTATRSLOBXFLVISITNUMRSDTC
1
RowSTUDYIDDOMAINUSUBJIDRSSEQRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSSTRESNRSSTATRSLOBXFLVISITNUMRSDTC
1STUDYXRSP00011KFSS101KFSS1-Pyramidal FunctionsKFSSMinimal disability22
Y12012-11-16
2STUDYXRSP00012KFSS102KFSS1-Cerebellar FunctionsKFSSMild ataxia22
Y12012-11-16
3
STUDYXRSP0001
1
3
EDSS0101
KFSS102A
EDSS01-Expanded Disability ScoreEDSSNormal neurological exam.0
KFSS1-Weakness Interferes With TestingKFSSNOT CHECKEDNOT CHECKED
0

Y12012-11-16
2
4STUDYXRS
P0002
P0001
1
4
EDSS0101
KFSS103
EDSS01-Expanded Disability ScoreEDSSNo disability, minimal signs in one FS.1
KFSS1-Brain Stem FunctionsKFSSNormal00
1

Y12012-11-16
3
5STUDYXRS
P0003
P0001
1
5
EDSS0101
KFSS104
EDSS01-Expanded Disability ScoreEDSSNo disability, minimal signs in more than one FS.1.5
KFSS1-Sensory FunctionsKFSSVibration or figure-writing decrease only, in one or two limbs11
1.5

Y12012-11-16
4
6STUDYXRS
P0004
P0001
1
6
EDSS0101
KFSS105
EDSS01-Expanded Disability ScoreEDSSMinimal disability in one FS.2
KFSS1-Bowel and Bladder FunctionsKFSSNormal00
2

Y12012-11-16
5
7STUDYXRS
P0005
P0001
1
7
EDSS0101
KFSS106
EDSS01-Expanded Disability ScoreEDSSMinimal disability in two FS.2.5
KFSS1-Visual or Optic FunctionsKFSSScotoma with visual acuity (corrected) better than 20/3011
2.5

Y12012-11-16
6
8STUDYXRS
P0006
P0001
1
8
EDSS0101
KFSS106A
EDSS01-Expanded Disability ScoreEDSSModerate disability in one FS or mild disability in three or four FS though fully ambulatory.3
KFSS1-Presence of Temporal PallorKFSSCHECKEDCHECKED
3


Y12012-11-16
7
9STUDYXRS
P0007
P0001
1
9
EDSS0101
KFSS107
EDSS01-Expanded Disability ScoreEDSSFully ambulatory but with moderate disability in one FS and one or two FS grade 2; or two FS grade 3 or five grade 2.3.53.5
KFSS1-Cerebral or Mental FunctionsKFSSUnknownUnknown

Y12012-11-16
8
10STUDYXRS
P0008
P0001
1
10
EDSS0101
KFSS108
EDSS01-Expanded Disability ScoreEDSSFully ambulatory without aid, self-sufficient, up and about some 12 hours a day despite relatively severe disability; able to walk without aid or rest some 500 meters.4
KFSS1-Other FunctionsKFSSNone00
4

Y12012-11-16
9
11STUDYXRS
P0009
P0001
1
11
EDSS0101
KFSS108A
EDSS01-Expanded Disability ScoreEDSSFully ambulatory without aid, up much of the day, able to work a full day, may have some limitation of full activity or require minimal assistance; able to walk without aid or rest some 300 meters.4.54.5
KFSS1-Other Functions SpecifyKFSS


NOT DONEY12012-11-16
10
12STUDYXRS
P0010
P0001
1
12
EDSS0101
KFSS101
EDSS01-Expanded Disability ScoreEDSSAmbulatory without aid or rest for about 200 meters; disability severe enough to impair full daily activities (e.g., to work a full day without special provisions).55Y12012-11-16
KFSS1-Pyramidal FunctionsKFSS


NOT DONE
22012-12-16
13
11
STUDYXRS
P0011
P0001
1
13
EDSS0101
KFSS102
EDSS01-Expanded Disability ScoreEDSSAmbulatory without aid for about 100 meters; disability severe enough to preclude full daily activities.5.55.5Y12012-11-16
KFSS1-Cerebellar FunctionsKFSS


NOT DONE
22012-12-16
14
12
STUDYXRS
P0012
P0001
1
14
EDSS0101
KFSS102A
EDSS01-Expanded Disability ScoreEDSSIntermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting.66Y12012-11-16
KFSS1-Weakness Interferes With TestingKFSS


NOT DONE
22012-12-16
15STUDYXRSP000115KFSS103KFSS1-Brain Stem FunctionsKFSS


NOT DONE
22012-12-16
16
13
STUDYXRS
P0013
P0001
1
16
EDSS0101
KFSS104
EDSS01-Expanded Disability ScoreEDSSConstant bilateral assistance (canes, crutches, braces) required to walk about 20 meters without resting.6.56.5Y12012-11-16
KFSS1-Sensory FunctionsKFSS


NOT DONE
22012-12-16
17
14
STUDYXRS
P0014
P0001
1
17
EDSS0101
KFSS105KFSS1-Bowel and Bladder FunctionsKFSS


NOT DONE
22012-12-16
18STUDYXRSP000118KFSS106KFSS1-Visual or Optic FunctionsKFSS


NOT DONE
22012-12-16
19STUDYXRSP000119KFSS106AKFSS1-Presence of Temporal PallorKFSS


NOT DONE
22012-12-16
20STUDYXRSP000120KFSS107KFSS1-Cerebral or Mental FunctionsKFSS


NOT DONE
22012-12-16
21STUDYXRSP000121KFSS108KFSS1-Other FunctionsKFSS


NOT DONE
22012-12-16
22STUDYXRSP000122KFSS108AKFSS1-Other Functions SpecifyKFSS


NOT DONE
2

2012-12-16

Dataset wrap
Namersedss
Rowcaps
Row 1:Represent he subjects EDSS score based on the subjects KFSS visit 1 responses including 2 FS grade 2 and others either 0 or 1 responses.
Row 2:

Represent that the subject

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyQRSSUPP-391
that was not evaluated on this instrument at visit 2. Since the visit was missed, the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred

Dataset2
16P00161
RowSTUDYIDDOMAINUSUBJIDRSSEQRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSSTRESNRSSTATRSLOBXFLVISITNUMRSDTC
1STUDYXRSP0001EDSS01-Expanded Disability ScoreEDSSUnable to walk beyond approximately 5 meters even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair and transfers alone; up and about in wheelchair some 12 hrs a day.77Y12012-11-1615STUDYXRSP00151EDSS0101EDSS01-Expanded Disability ScoreEDSSUnable to take more than a few steps; restricted to wheelchair; may need aid in transfer; wheels self but cannot carry on in standard wheelchair a full day; May require motorized wheelchair.7.5Minimal disability in two FS.2.527.5
Y12012-11-16
2STUDYXRSP00011EDSS0101EDSS01-Expanded Disability ScoreEDSS


NOT DONE

2

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyQRSSUPP-390



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.

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