ID

16074

Beskrivning

NINDS Common Data Elements, Multiple Sclerosis Relapse Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

Länk

https://www.commondataelements.ninds.nih.gov/

Nyckelord

Versioner (1)
  1. 2016-06-28 2016-06-28 -
Uppladdad den

28 juni 2016

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NINDS CDERelapse Multiple Sclerosis

Engelsk

Relapse

1 Formulär  
  1. StudyEvent: ODM
    1. Relapse
Relapse
Beskrivning

Relapse

Alias
UMLS CUI-1
C0035020
Study ID
Beskrivning

Study ID

Datatyp

integer

Alias
UMLS CUI [1]
C2826693
Study site name
Beskrivning

Study site name

Datatyp

text

Alias
UMLS CUI [1]
C2825164
Subject ID
Beskrivning

Subject ID

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
1. Is the participant/subject having new neurologic symptom(s) or an acute worsening of preexisting neurologic symptoms?
Beskrivning

neurologic symptom

Datatyp

text

Alias
UMLS CUI [1]
C0235031
a. If Yes, Date of onset:
Beskrivning

Date of onset

Datatyp

date

Alias
UMLS CUI [1]
C0574845
i. Did the symptoms last more than 24 hours?
Beskrivning

neurologic symptom

Datatyp

text

Alias
UMLS CUI [1]
C0235031
2. Did the participant/subject have a fever due to intercurrent illness?
Beskrivning

fever

Datatyp

text

Alias
UMLS CUI [1]
C0015967
3. Prior to the onset of this event, were the participant’s/subject’s MS symptom(s) stable or improving over the last 30 days?
Beskrivning

MS symptom

Datatyp

text

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C1457887
a. If Yes, was onset within the last 24 hours?
Beskrivning

symptom onset

Datatyp

text

Alias
UMLS CUI [1]
C0277793
b. If No, was the onset within the last 7 days?
Beskrivning

symptom onset

Datatyp

text

Alias
UMLS CUI [1]
C0277793
4. Are the symptom(s) associated with new neurologic findings?
Beskrivning

neurologic findings

Datatyp

text

Alias
UMLS CUI [1]
C0422837
Pyramidal system
Beskrivning

Pyramidal system

Datatyp

boolean

Alias
UMLS CUI [1]
C0228060
Sensory system
Beskrivning

Sensory system

Datatyp

boolean

Alias
UMLS CUI [1]
C0682648
Cerebellar
Beskrivning

Cerebellar

Datatyp

boolean

Alias
UMLS CUI [1]
C0007765
Bowel and/or Bladder
Beskrivning

Bladder and bowel

Datatyp

boolean

Alias
UMLS CUI [1]
C2707247
Brainstem
Beskrivning

Brainstem

Datatyp

boolean

Alias
UMLS CUI [1]
C0006121
Mental
Beskrivning

Mental

Datatyp

boolean

Alias
UMLS CUI [1]
C0004936
Visual
Beskrivning

Visual

Datatyp

boolean

Alias
UMLS CUI [1]
C0042789
5. Are the participant’s/subject’s symptom(s) ongoing?
Beskrivning

ongoing symptoms

Datatyp

text

Alias
UMLS CUI [1]
C2826680
a. If No, End Date:
Beskrivning

End Date

Datatyp

date

Alias
UMLS CUI [1]
C0806020
6. Please describe event, symptom(s) and treatment that occured with the participant/subject:
Beskrivning

symptom; treatment

Datatyp

text

Alias
UMLS CUI [1]
C1457887
UMLS CUI [2]
C0039798
7. If applicable, is this a protocol defined qualifying relapse according to the definition set in the study protocol?
Beskrivning

study protocol; relapse

Datatyp

text

Alias
UMLS CUI [1]
C2348563
UMLS CUI [2]
C0035020
a. If No, please indicate why the event is not a qualifying relapse as defined in the protocol:
Beskrivning

relapse

Datatyp

text

Alias
UMLS CUI [1]
C0277556
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Similar models

Relapse

1 Formulär
  1. StudyEvent: ODM
    1. Relapse
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Relapse
C0035020 (UMLS CUI-1)
Study ID
Item
Study ID
integer
C2826693 (UMLS CUI [1])
Study site name
Item
Study site name
text
C2825164 (UMLS CUI [1])
Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Item
1. Is the participant/subject having new neurologic symptom(s) or an acute worsening of preexisting neurologic symptoms?
text
C0235031 (UMLS CUI [1])
neurologic symptom
Code List
1. Is the participant/subject having new neurologic symptom(s) or an acute worsening of preexisting neurologic symptoms?
CL Item
yes (1)
CL Item
no (stop) (2)
CL Item
unknown (3)
Date of onset
Item
a. If Yes, Date of onset:
date
C0574845 (UMLS CUI [1])
Item
i. Did the symptoms last more than 24 hours?
text
C0235031 (UMLS CUI [1])
neurologic symptom
Code List
i. Did the symptoms last more than 24 hours?
CL Item
yes (1)
CL Item
no (Skip to Q8) (2)
CL Item
unknown (3)
Item
2. Did the participant/subject have a fever due to intercurrent illness?
text
C0015967 (UMLS CUI [1])
fever
Code List
2. Did the participant/subject have a fever due to intercurrent illness?
CL Item
Yes (Skip to Q8)  (1)
CL Item
No (2)
Item
3. Prior to the onset of this event, were the participant’s/subject’s MS symptom(s) stable or improving over the last 30 days?
text
C0026769 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
MS symptom
Code List
3. Prior to the onset of this event, were the participant’s/subject’s MS symptom(s) stable or improving over the last 30 days?
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
Item
a. If Yes, was onset within the last 24 hours?
text
C0277793 (UMLS CUI [1])
MS symptom
Code List
a. If Yes, was onset within the last 24 hours?
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
Item
b. If No, was the onset within the last 7 days?
text
C0277793 (UMLS CUI [1])
MS symptom
Code List
b. If No, was the onset within the last 7 days?
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
Item
4. Are the symptom(s) associated with new neurologic findings?
text
C0422837 (UMLS CUI [1])
neurologic findings
Code List
4. Are the symptom(s) associated with new neurologic findings?
CL Item
yes [If Yes, in which system(s) was/is the deficit present? (Choose all that apply)] (1)
CL Item
no  (2)
CL Item
unknown (3)
Pyramidal system
Item
Pyramidal system
boolean
C0228060 (UMLS CUI [1])
Sensory system
Item
Sensory system
boolean
C0682648 (UMLS CUI [1])
Cerebellar
Item
Cerebellar
boolean
C0007765 (UMLS CUI [1])
Bladder and bowel
Item
Bowel and/or Bladder
boolean
C2707247 (UMLS CUI [1])
Brainstem
Item
Brainstem
boolean
C0006121 (UMLS CUI [1])
Mental
Item
Mental
boolean
C0004936 (UMLS CUI [1])
Visual
Item
Visual
boolean
C0042789 (UMLS CUI [1])
Item
5. Are the participant’s/subject’s symptom(s) ongoing?
text
C2826680 (UMLS CUI [1])
MS symptom
Code List
5. Are the participant’s/subject’s symptom(s) ongoing?
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
End Date
Item
a. If No, End Date:
date
C0806020 (UMLS CUI [1])
symptom; treatment
Item
6. Please describe event, symptom(s) and treatment that occured with the participant/subject:
text
C1457887 (UMLS CUI [1])
C0039798 (UMLS CUI [2])
Item
7. If applicable, is this a protocol defined qualifying relapse according to the definition set in the study protocol?
text
C2348563 (UMLS CUI [1])
C0035020 (UMLS CUI [2])
MS symptom
Code List
7. If applicable, is this a protocol defined qualifying relapse according to the definition set in the study protocol?
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
relapse
Item
a. If No, please indicate why the event is not a qualifying relapse as defined in the protocol:
text
C0277556 (UMLS CUI [1])
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