ID

16074

Description

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.

Lien

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

Mots-clés

Versions (1)
  1. 28/06/2016 28/06/2016 -
Téléchargé le

28 juin 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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NINDS CDERelapse Multiple Sclerosis

Anglais

Relapse

1 Formulaires  
  1. StudyEvent: ODM
    1. Relapse
Relapse
Description

Relapse

Alias
UMLS CUI-1
C0035020
Study ID
Description

Study ID

Type de données

integer

Alias
UMLS CUI [1]
C2826693
Study site name
Description

Study site name

Type de données

text

Alias
UMLS CUI [1]
C2825164
Subject ID
Description

Subject ID

Type de données

integer

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

neurologic symptom

Type de données

text

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

Date of onset

Type de données

date

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

neurologic symptom

Type de données

text

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

fever

Type de données

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?
Description

MS symptom

Type de données

text

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

symptom onset

Type de données

text

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

symptom onset

Type de données

text

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

neurologic findings

Type de données

text

Alias
UMLS CUI [1]
C0422837
Pyramidal system
Description

Pyramidal system

Type de données

boolean

Alias
UMLS CUI [1]
C0228060
Sensory system
Description

Sensory system

Type de données

boolean

Alias
UMLS CUI [1]
C0682648
Cerebellar
Description

Cerebellar

Type de données

boolean

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

Bladder and bowel

Type de données

boolean

Alias
UMLS CUI [1]
C2707247
Brainstem
Description

Brainstem

Type de données

boolean

Alias
UMLS CUI [1]
C0006121
Mental
Description

Mental

Type de données

boolean

Alias
UMLS CUI [1]
C0004936
Visual
Description

Visual

Type de données

boolean

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

ongoing symptoms

Type de données

text

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

End Date

Type de données

date

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

symptom; treatment

Type de données

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?
Description

study protocol; relapse

Type de données

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:
Description

relapse

Type de données

text

Alias
UMLS CUI [1]
C0277556
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Similar models

Relapse

1 Formulaires
  1. StudyEvent: ODM
    1. Relapse
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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