ID

43678

Beschreibung

NINDS Common Data Elements 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.

Link

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

Stichworte

Versionen (2)
  1. 26.04.16 26.04.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY-NC 3.0
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NINDS CDE Devices Epilepsy

Englisch

Devices

1 Formulare  
  1. StudyEvent: ODM
    1. Devices
Device Revision/Replacement Log
Beschreibung

Device Revision/Replacement Log

Study ID
Beschreibung

Study ID

Datentyp

text

Alias
UMLS CUI [1]
C2826693
Study site name
Beschreibung

Study site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Subject ID
Beschreibung

Subject ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Line number
Beschreibung

Line

Datentyp

integer

Alias
UMLS CUI [1]
C0750480
Device and device number on Devices Log
Beschreibung

Device

Datentyp

text

Alias
UMLS CUI [1]
C0699733
Date of revision
Beschreibung

Date of revision

Datentyp

date

Alias
UMLS CUI [1,1]
C1527075
UMLS CUI [1,2]
C0011008
Implantable Neurostimulator
Beschreibung

Implantable Neurostimulator

Datentyp

integer

Alias
UMLS CUI [1]
C2048402
Implantable Neurostimulator:Model Nr. of new INS
Beschreibung

Implantable Neurostimulator

Datentyp

integer

Alias
UMLS CUI [1]
C2048402
Implantable Neurostimulator: Device registration Nr of new INS
Beschreibung

Implantable Neurostimulator

Datentyp

integer

Alias
UMLS CUI [1]
C2048402
INS Lead (LEFT)
Beschreibung

INS Lead (LEFT)

Datentyp

integer

Alias
UMLS CUI [1]
C0993765
INS Lead (LEFT): Model Nr of new lead
Beschreibung

INS Lead (LEFT)

Datentyp

integer

Alias
UMLS CUI [1]
C0993765
INS Lead (LEFT): Device registration Nr of new lead
Beschreibung

INS Lead (LEFT)

Datentyp

integer

Alias
UMLS CUI [1]
C0993765
INS Lead (RIGHT) if applicable
Beschreibung

INS Lead (RIGHT) if applicable

Datentyp

integer

Alias
UMLS CUI [1]
C0993765
INS Lead (RIGHT) if applicable: Model Nr of new lead
Beschreibung

INS Lead (RIGHT) if applicable

Datentyp

integer

Alias
UMLS CUI [1]
C0993765
INS Lead (RIGHT) if applicable: Device registration Nr of new lead
Beschreibung

INS Lead (RIGHT) if applicable

Datentyp

integer

Alias
UMLS CUI [1]
C0993765
INS Extension (LEFT) if applicable
Beschreibung

INS Extension (LEFT) if applicable

Datentyp

integer

Alias
UMLS CUI [1]
C0993787
INS Extension (LEFT) if applicable: Model Nr of new extension
Beschreibung

INS Extension (LEFT) if applicable

Datentyp

integer

Alias
UMLS CUI [1]
C0993787
INS Extension (LEFT) if applicable: Device registration Nr of new extension
Beschreibung

INS Extension (LEFT) if applicable

Datentyp

integer

Alias
UMLS CUI [1]
C0993787
INS Extension (RIGHT) if applicable
Beschreibung

INS Extension (RIGHT) if applicable

Datentyp

integer

Alias
UMLS CUI [1]
C0993787
INS Extension (RIGHT) if applicable: Model Nr of new extension
Beschreibung

INS Extension (RIGHT) if applicable

Datentyp

integer

Alias
UMLS CUI [1]
C0993787
INS Extension (RIGHT) if applicable: Device registration Nr of new extension
Beschreibung

INS Extension (RIGHT) if applicable

Datentyp

integer

Alias
UMLS CUI [1]
C0993787
INS: Other component
Beschreibung

INS Other component

Datentyp

integer

Alias
UMLS CUI [1,1]
C2048402
UMLS CUI [1,2]
C0449432
INS other: Model Nr of other new component
Beschreibung

INS other component

Datentyp

integer

Alias
UMLS CUI [1,1]
C2048402
UMLS CUI [1,2]
C0449432
INS Other component: Device registration Nr of other new component
Beschreibung

INS Other component

Datentyp

integer

Alias
UMLS CUI [1,1]
C2048402
UMLS CUI [1,2]
C0449432
Clinical Condition if applicable, reason for the device revision/replacement
Beschreibung

Reason for the device revision/replacement

Datentyp

integer

Alias
UMLS CUI [1,1]
C1527075
UMLS CUI [1,2]
C0566251
Reason for the device revision/replacement:please specify
Beschreibung

Reason for the device revision/replacement

Datentyp

text

Alias
UMLS CUI [1,1]
C1527075
UMLS CUI [1,2]
C0566251
Devices Log
Beschreibung

Devices Log

Line number
Beschreibung

Line

Datentyp

integer

Alias
UMLS CUI [1]
C0750480
Device name
Beschreibung

Device

Datentyp

integer

Alias
UMLS CUI [1]
C2825207
Device name,please specify
Beschreibung

Device

Datentyp

text

Alias
UMLS CUI [1]
C2825207
Date of initial implant
Beschreibung

Date of implant

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021107
Device Manufacturer
Beschreibung

Device Manufacturer

Datentyp

text

Alias
UMLS CUI [1]
C0947322
Device Registration Nr or Serial Nr
Beschreibung

Device Registration Nr or Serial Nr

Datentyp

integer

Alias
UMLS CUI [1]
C2348188
UMLS CUI [2]
C3830169
Device Registration Nr or Serial Nr
Beschreibung

Device Registration Nr or Serial Nr

Datentyp

integer

Alias
UMLS CUI [1]
C2348188
UMLS CUI [2]
C3830169
Stimulation Target
Beschreibung

Stimulation Target

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013786
UMLS CUI [1,2]
C1521840
Stimulation Target:please specify other target
Beschreibung

Stimulation Target

Datentyp

text

Alias
UMLS CUI [1,1]
C0013786
UMLS CUI [1,2]
C1521840
Type of Lead
Beschreibung

Type of Lead

Datentyp

integer

Alias
UMLS CUI [1,1]
C0181586
UMLS CUI [1,2]
C0332307
Type of Lead: Depth; Nr Contacts
Beschreibung

Type of Lead

Datentyp

integer

Alias
UMLS CUI [1,1]
C0181586
UMLS CUI [1,2]
C0332307
Type of Lead: Strip; Nr Contacts
Beschreibung

Type of Lead

Datentyp

integer

Alias
UMLS CUI [1,1]
C0181586
UMLS CUI [1,2]
C0332307
Type of Lead: please specify other
Beschreibung

Type of Lead

Datentyp

text

Alias
UMLS CUI [1,1]
C0181586
UMLS CUI [1,2]
C0332307
Location of Neurostimulator
Beschreibung

Location of Neurostimulator

Datentyp

integer

Alias
UMLS CUI [1,1]
C2048402
UMLS CUI [1,2]
C0450429
Location of Neurostimulator:please specify "other"
Beschreibung

Location of Neurostimulator

Datentyp

text

Alias
UMLS CUI [1,1]
C2048402
UMLS CUI [1,2]
C0450429
Date of Permanent Explant (if applicable)
Beschreibung

Date of explant

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0561946
Is any part of the device left in the body?
Beschreibung

Device

Datentyp

boolean

Alias
UMLS CUI [1]
C0699733
Is any part of the device left in the body? If yes, please specify
Beschreibung

Device

Datentyp

text

Alias
UMLS CUI [1]
C0699733
If applicable, Reason for Discontinuation
Beschreibung

Reason for Discontinuation

Datentyp

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
Reason for Discontinuation: please specify
Beschreibung

Reason for Discontinuation

Datentyp

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
Implanted Devices Log
Beschreibung

Implanted Devices Log

Line number and number of device on Devices Log
Beschreibung

Line

Datentyp

integer

Alias
UMLS CUI [1]
C0750480
Device Type
Beschreibung

Device

Datentyp

text

Alias
UMLS CUI [1]
C0699733
Start date
Beschreibung

Start date

Datentyp

date

Maßeinheiten
  • mm/dd/yyyy
Alias
UMLS CUI [1]
C0808070
mm/dd/yyyy
End date
Beschreibung

End date

Datentyp

date

Maßeinheiten
  • mm/dd/yyyy
Alias
UMLS CUI [1]
C0806020
mm/dd/yyyy
Amperage
Beschreibung

Amperage

Datentyp

integer

Maßeinheiten
  • mA
Alias
UMLS CUI [1]
C0598350
mA
Voltage
Beschreibung

Voltage

Datentyp

integer

Alias
UMLS CUI [1]
C0450002
Frequency
Beschreibung

Frequency

Datentyp

float

Maßeinheiten
  • Hz
Alias
UMLS CUI [1]
C0439603
Hz
Pulse Width
Beschreibung

Pulse Width

Datentyp

integer

Maßeinheiten
  • uSec
Alias
UMLS CUI [1]
C0510119
uSec
Stimulation Duration ON
Beschreibung

Stimulation Duration ON

Datentyp

integer

Maßeinheiten
  • mins
Alias
UMLS CUI [1]
C0237586
mins
Stimulation Duration OFF
Beschreibung

Stimulation Duration OFF

Datentyp

integer

Maßeinheiten
  • mins
Alias
UMLS CUI [1]
C0237586
mins
Positive Electrode Count if applicable
Beschreibung

Positive Electrode Count

Datentyp

integer

Alias
UMLS CUI [1,1]
C0003103
UMLS CUI [1,2]
C0750480
Negative electrode count if applicable
Beschreibung

Negative electrode count

Datentyp

integer

Alias
UMLS CUI [1,1]
C0007441
UMLS CUI [1,2]
C0750480
If applicable, reason for modifying parameters or electrode configuration
Beschreibung

Reason for modification

Datentyp

integer

Alias
UMLS CUI [1,1]
C0579005
UMLS CUI [1,2]
C0566251
Reason for modifying parameters or electrode configuration, please specify
Beschreibung

Reason for modification

Datentyp

text

Alias
UMLS CUI [1,1]
C0579005
UMLS CUI [1,2]
C0566251
Further comments
Beschreibung

Further comments

Datentyp

text

Alias
UMLS CUI [1]
C1830770
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Ähnliche Modelle

Devices

1 Formulare
  1. StudyEvent: ODM
    1. Devices
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Device Revision/Replacement Log
Study ID
Item
Study ID
text
C2826693 (UMLS CUI [1])
Study site
Item
Study site name
text
C2825164 (UMLS CUI [1])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Line
Item
Line number
integer
C0750480 (UMLS CUI [1])
Device
Item
Device and device number on Devices Log
text
C0699733 (UMLS CUI [1])
Date of revision
Item
Date of revision
date
C1527075 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Implantable Neurostimulator
integer
C2048402 (UMLS CUI [1])
INS
Code List
Implantable Neurostimulator
CL Item
Explant and replace on same day (1)
CL Item
Explant only (2)
CL Item
Replacement only (previously explanted) (3)
CL Item
Repositioned (4)
Implantable Neurostimulator
Item
Implantable Neurostimulator:Model Nr. of new INS
integer
C2048402 (UMLS CUI [1])
Implantable Neurostimulator
Item
Implantable Neurostimulator: Device registration Nr of new INS
integer
C2048402 (UMLS CUI [1])
Item
INS Lead (LEFT)
integer
C0993765 (UMLS CUI [1])
INS
Code List
INS Lead (LEFT)
CL Item
Explant and replace on same day (1)
CL Item
Explant only (2)
CL Item
Replacement only (previously explanted) (3)
CL Item
Repositioned (4)
INS Lead (LEFT)
Item
INS Lead (LEFT): Model Nr of new lead
integer
C0993765 (UMLS CUI [1])
INS Lead (LEFT)
Item
INS Lead (LEFT): Device registration Nr of new lead
integer
C0993765 (UMLS CUI [1])
Item
INS Lead (RIGHT) if applicable
integer
C0993765 (UMLS CUI [1])
INS
Code List
INS Lead (RIGHT) if applicable
CL Item
Explant and replace on same day (1)
CL Item
Explant only (2)
CL Item
Replacement only (previously explanted) (3)
CL Item
Repositioned (4)
INS Lead (RIGHT) if applicable
Item
INS Lead (RIGHT) if applicable: Model Nr of new lead
integer
C0993765 (UMLS CUI [1])
INS Lead (RIGHT) if applicable
Item
INS Lead (RIGHT) if applicable: Device registration Nr of new lead
integer
C0993765 (UMLS CUI [1])
Item
INS Extension (LEFT) if applicable
integer
C0993787 (UMLS CUI [1])
INS
Code List
INS Extension (LEFT) if applicable
CL Item
Explant and replace on same day (1)
CL Item
Explant only (2)
CL Item
Replacement only (previously explanted) (3)
CL Item
Repositioned (4)
INS Extension (LEFT) if applicable
Item
INS Extension (LEFT) if applicable: Model Nr of new extension
integer
C0993787 (UMLS CUI [1])
INS Extension (LEFT) if applicable
Item
INS Extension (LEFT) if applicable: Device registration Nr of new extension
integer
C0993787 (UMLS CUI [1])
Item
INS Extension (RIGHT) if applicable
integer
C0993787 (UMLS CUI [1])
INS
Code List
INS Extension (RIGHT) if applicable
CL Item
Explant and replace on same day (1)
CL Item
Explant only (2)
CL Item
Replacement only (previously explanted) (3)
CL Item
Repositioned (4)
INS Extension (RIGHT) if applicable
Item
INS Extension (RIGHT) if applicable: Model Nr of new extension
integer
C0993787 (UMLS CUI [1])
INS Extension (RIGHT) if applicable
Item
INS Extension (RIGHT) if applicable: Device registration Nr of new extension
integer
C0993787 (UMLS CUI [1])
Item
INS: Other component
integer
C2048402 (UMLS CUI [1,1])
C0449432 (UMLS CUI [1,2])
INS
Code List
INS: Other component
CL Item
Explant and replace on same day (1)
CL Item
Explant only (2)
CL Item
Replacement only (previously explanted) (3)
CL Item
Repositioned (4)
INS other component
Item
INS other: Model Nr of other new component
integer
C2048402 (UMLS CUI [1,1])
C0449432 (UMLS CUI [1,2])
INS Other component
Item
INS Other component: Device registration Nr of other new component
integer
C2048402 (UMLS CUI [1,1])
C0449432 (UMLS CUI [1,2])
Item
Clinical Condition if applicable, reason for the device revision/replacement
integer
C1527075 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason for the device revision/replacement
Code List
Clinical Condition if applicable, reason for the device revision/replacement
CL Item
Serious Adverse Device Effect, specify (1)
CL Item
Intolerable Stimulation Related Adverse Event, specify (2)
CL Item
Other Adverse Event, specify (3)
CL Item
Inadequate Seizure Control (4)
CL Item
Other, specify (5)
Reason for the device revision/replacement
Item
Reason for the device revision/replacement:please specify
text
C1527075 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Item Group
Devices Log
Line
Item
Line number
integer
C0750480 (UMLS CUI [1])
Item
Device name
integer
C2825207 (UMLS CUI [1])
Device
Code List
Device name
CL Item
VNS (1)
CL Item
DBS (2)
CL Item
RNS (3)
CL Item
Other, specify (4)
Device
Item
Device name,please specify
text
C2825207 (UMLS CUI [1])
Date of implant
Item
Date of initial implant
date
C0011008 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
Device Manufacturer
Item
Device Manufacturer
text
C0947322 (UMLS CUI [1])
Item
Device Registration Nr or Serial Nr
integer
C2348188 (UMLS CUI [1])
C3830169 (UMLS CUI [2])
Device Registration Nr or Serial Nr
Code List
Device Registration Nr or Serial Nr
CL Item
INS (1)
CL Item
Lead (2)
CL Item
Extension (if applicable) (3)
Device Registration Nr or Serial Nr
Item
Device Registration Nr or Serial Nr
integer
C2348188 (UMLS CUI [1])
C3830169 (UMLS CUI [2])
Item
Stimulation Target
integer
C0013786 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
Stimulation Target
Code List
Stimulation Target
CL Item
Left Vagus Nerve (1)
CL Item
Hippocampus (2)
CL Item
Left side (3)
CL Item
Right side (4)
CL Item
AN (5)
CL Item
Unilateral (6)
CL Item
Bilateral (7)
CL Item
Other, specify (8)
Stimulation Target
Item
Stimulation Target:please specify other target
text
C0013786 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
Item
Type of Lead
integer
C0181586 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of Lead
Code List
Type of Lead
CL Item
VNS (1)
CL Item
Depth; # Contacts (2)
CL Item
Strip; # Contacts (3)
CL Item
Other, specify (4)
Type of Lead
Item
Type of Lead: Depth; Nr Contacts
integer
C0181586 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of Lead
Item
Type of Lead: Strip; Nr Contacts
integer
C0181586 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of Lead
Item
Type of Lead: please specify other
text
C0181586 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Item
Location of Neurostimulator
integer
C2048402 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Location of Neurostimulator
Code List
Location of Neurostimulator
CL Item
Right Chest (1)
CL Item
Left Chest (2)
CL Item
Other, specify (3)
Location of Neurostimulator
Item
Location of Neurostimulator:please specify "other"
text
C2048402 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Date of explant
Item
Date of Permanent Explant (if applicable)
date
C0011008 (UMLS CUI [1,1])
C0561946 (UMLS CUI [1,2])
Device
Item
Is any part of the device left in the body?
boolean
C0699733 (UMLS CUI [1])
Device
Item
Is any part of the device left in the body? If yes, please specify
text
C0699733 (UMLS CUI [1])
Item
If applicable, Reason for Discontinuation
integer
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Reason for the device revision/replacement
Code List
If applicable, Reason for Discontinuation
CL Item
Serious Adverse Device Effect, specify (1)
CL Item
Intolerable Stimulation Related Adverse Event, specify (2)
CL Item
Other Adverse Event, specify (3)
CL Item
Inadequate Seizure Control (4)
CL Item
Other, specify (5)
Reason for Discontinuation
Item
Reason for Discontinuation: please specify
text
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Item Group
Implanted Devices Log
Line
Item
Line number and number of device on Devices Log
integer
C0750480 (UMLS CUI [1])
Device
Item
Device Type
text
C0699733 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Amperage
Item
Amperage
integer
C0598350 (UMLS CUI [1])
Voltage
Item
Voltage
integer
C0450002 (UMLS CUI [1])
Frequency
Item
Frequency
float
C0439603 (UMLS CUI [1])
Pulse Width
Item
Pulse Width
integer
C0510119 (UMLS CUI [1])
Stimulation Duration ON
Item
Stimulation Duration ON
integer
C0237586 (UMLS CUI [1])
Stimulation Duration OFF
Item
Stimulation Duration OFF
integer
C0237586 (UMLS CUI [1])
Positive Electrode Count
Item
Positive Electrode Count if applicable
integer
C0003103 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Negative electrode count
Item
Negative electrode count if applicable
integer
C0007441 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Item
If applicable, reason for modifying parameters or electrode configuration
integer
C0579005 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason for the device revision/replacement
Code List
If applicable, reason for modifying parameters or electrode configuration
CL Item
Serious Adverse Device Effect, specify (1)
CL Item
Intolerable Stimulation Related Adverse Event, specify (2)
CL Item
Other Adverse Event, specify (3)
CL Item
Inadequate Seizure Control (4)
CL Item
Other, specify (5)
Reason for modification
Item
Reason for modifying parameters or electrode configuration, please specify
text
C0579005 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Further comments
Item
Further comments
text
C1830770 (UMLS CUI [1])
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