Informações:
Falhas:
ID
43678
Descrição
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/
Palavras-chave
Versões (2)
- 26/04/2016 26/04/2016 -
- 20/09/2021 20/09/2021 -
Transferido a
20 de setembro de 2021
DOI
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Licença
Creative Commons BY-NC 3.0
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NINDS CDE Devices Epilepsy
Similar models
Devices
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
C0011008 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
C0449432 (UMLS CUI [1,2])
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])
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])
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])
C0566251 (UMLS CUI [1,2])
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])
C0566251 (UMLS CUI [1,2])
Line
Item
Line number
integer
C0750480 (UMLS CUI [1])
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])
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])
C3830169 (UMLS CUI [2])
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])
C3830169 (UMLS CUI [2])
Item
Stimulation Target
integer
C0013786 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,2])
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])
C1521840 (UMLS CUI [1,2])
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])
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])
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])
C0332307 (UMLS CUI [1,2])
Item
Location of Neurostimulator
integer
C2048402 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
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])
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])
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])
C0457454 (UMLS CUI [1,2])
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])
C0457454 (UMLS CUI [1,2])
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])
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])
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])
C0566251 (UMLS CUI [1,2])
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])
C0566251 (UMLS CUI [1,2])
Further comments
Item
Further comments
text
C1830770 (UMLS CUI [1])