CDE Detailed Report

Disease: system
Subdomain Name: Surgeries and Other Procedures
CRF: files

Displaying 101 - 114 of 114
CDE ID CDE Name Variable Name Definition Short Description Question Text Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guidance) Subdomain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C02305 Adverse event severity scale grade AdvrsEvntSeverSclGrade The grading scale of the severity or intensity of the adverse event The grading scale of the severity or intensity of the adverse event Complications Severity Grade 1;Grade 3;Grade 5;Grade 2;Grade 4 Asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated;Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, limiting self care Activities of Daily Living;Death;Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living;Life-threatening consequences, urgent intervention indicated Alphanumeric

Choose the one severity that best describes the investigator's assessment of the intensity of the AE. The five severity grades are from the Common Terminology Criteria for Adverse Events v5.0 (CTCAE). Severe events interrupt the participant's/subject's normal daily activities and generally require systemic drug therapy or other treatment; they are usually incapacitating. Consequently, a change in severity may constitute a new reportable AE. Severity is not synonymous with seriousness. A severe rash is not likely to be an SAE. Likewise, a severe headache is not necessarily an SAE. However, mild chest pain may result in a day's hospitalization and thus is an SAE. It is helpful to define the severity categories in the protocol or Manual of Operations to obtain consistency in reporting across sites.

 Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (https://evs.nci.nih.gov/ftp1/CTCAE/About.html) Adult Supplemental 5.00 2022-07-29 12:16:09.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

 2201188
C59153 Lead extender remove count LeadExtndrRemoveCt Count of lead extenders removed Count of lead extenders removed Lead extender (specify # of extenders removed) Numeric Values

No instructions available

 No references available Adult Supplemental 1.00 2022-07-28 11:20:05.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry
C18757 Surgery lead secure method type other text SurgLeadSecurMethdTypOTH The free-text field related to 'Surgery lead secure method type', specifying other text. Type of method or device used to protect and secure the lead (part of the electrode that is introduced into the brain), this part must be safely secured and held still Field related to 'Surgery lead secure method type', specifying other text. Type of method or device used to protect and secure the lead (part of the electrode that is introduced into the brain), this part must be safely secured and held still in position Other, specify Alphanumeric

Using the options listed, or free text, please specify the type of method or device used to protect and secure the lead (part of the electrode that is introduced into the brain), this part must be safely secured and held still in position

 No references available Adult Supplemental 1.10 2022-07-29 11:46:28.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry
C59131 Stimulation brain parameter positive contact text StimBrainParamPostveContactTxt Text related to positive contact brain stimulation parameters Text related to positive contact brain stimulation parameters Positive contacts(s) Alphanumeric

Answer for both left brain and right brain if applicable

 No references available Adult Supplemental 1.00 2022-07-28 10:32:19.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data 255

Free-Form Entry
C08035 Stereotactic surgery frame type StereotactSurgFrmTyp Scaffold or support used for stereotactic surgery Scaffold or support used for stereotactic surgery Mechanical guidance for lead insertion Other, specify;CRW headframe;Leksell headframe;Single use mini-frame Other, specify;CRW headframe;Leksell headframe;Single use mini-frame ("frameless") Alphanumeric

CRW (manufactured by Radionics) and Leksell (manufactured by Elekta) are the two most common frame types.
If 'mini-frame' is checked, specify the type

 No references available Adult Supplemental 3.10 2022-07-29 12:07:57.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected
C59586 Stereotactic surgery mini-frame type other text StereotactSurgMiniFrmTypOTH The free-text field related to 'Stereotactic surgery mini-frame type', specifying other text. Type of mini-frame used for surgery. A mini-frame is a simpler and smaller support for stereotactic surgery; used mainly in image-guided surgery The free-text field related to 'Stereotactic surgery mini-frame type', specifying other text. Type of mini-frame used for surgery. A mini-frame is a simpler and smaller support for stereotactic surgery; used mainly in image-guided surgery Other, specify Alphanumeric

Only answer if 'mini-frame' is answered for 'Frame Type'

 No references available Adult Supplemental 1.00 2022-08-18 16:54:57.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry
C59090 Deep brain stimulation indication type other text DBSIndicationTypOTH The free-text field related to 'Deep brain stimulation indication type', specifying other text. Type of indications for deep brain stimulation (DBS) The free-text field related to 'Deep brain stimulation indication type', specifying other text. Type of indications for deep brain stimulation (DBS) Other indication, specify Alphanumeric

No instructions available

 No references available Adult Supplemental 1.00 2022-07-28 09:27:45.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry
C59106 Surgery head fixation status SurgHeadFixationStatus Status of the participant's/subject's head fixation to the operating room table during surgery Status of the participant's/subject's head fixation to the operating room table during surgery Head fixation to operating room table Yes, specify;None Yes, specify;None Alphanumeric

No instructions available

 No references available Adult Supplemental 1.00 2022-07-28 09:42:27.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected
C59143 Unified Parkinsons Disease Rating Scale part three on DBS on medication score UPDRSPtThreeOnDBSOnMedScore The score related to part three of the Unified Parkinson's Disease Rating Scale (UPDRS) when the participant/subject is on DBS and on medications The score related to part three of the Unified Parkinson's Disease Rating Scale (UPDRS) when the participant/subject is on DBS and on medications UPDRS part 3 score, on DBS, on medication Numeric Values

No instructions available

 No references available Adult Supplemental 1.00 2022-07-28 10:57:03.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry
C08051 Stimulation parameter brain hemisphere type StimParamBrainHemisphTyp Side of the brain targeted for stimulation Side of the brain targeted for stimulation Left Brain Right Brain Right;Left Right Brain;Left Brain Alphanumeric

Choose all that apply

 No references available Adult Supplemental 3.10 2022-07-29 11:47:38.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Multiple Pre-Defined Values Selected
C59121 Brain lead cylindrical type other text BrainLeadCylindricalTypOTH The free-text field related to 'Brain lead type', specifying the other type of cylindrical lead inserted The free-text field related to 'Brain lead type', specifying the other type of cylindrical lead inserted Cylindrical-other Alphanumeric

No instructions available

 No references available Adult Supplemental 1.00 2022-07-28 10:20:42.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry
C02411 Laterality type LatTyp Laterality type relative to the anatomic site of the body examined or affected Laterality type relative to the anatomic site of the body examined or affected Structure targeted Left;Right Left;Right Alphanumeric

No instructions available

 No references available Adult Supplemental 3.00 2013-08-28 16:08:00.453 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected
C59154 Brain lead replacement manipulation count BrainLeadRplcmntMnpltnCt Count of brain leads replaced or manipulated Count of brain leads replaced or manipulated If yes, how many Numeric Values

No instructions available

 No references available Adult Supplemental 1.00 2022-07-28 11:21:12.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry
C18758 Surgery post-operative target verification method source other text SurgPstOpTrgtVrfMethdSourceOTH The free-text field related to 'Surgery post-operative target verification method source', specifying other text. Post-operative source method used for verifying the brain nucleus (target) was reached The free-text field related to 'Surgery post-operative target verification method source', specifying other text. Post-operative source method used for verifying the brain nucleus (target) was reached Other, specify Alphanumeric

Using the options listed, or free text, please specify the method used for post-operative target verification

 No references available Adult Supplemental 1.10 2022-07-29 11:47:16.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry
CSV