This form structure is an organized set of data definitions for a copyrighted form

 General Details

Title:
TBI-QOL Item Bank v1.0 - Headache Pain - Short Form 10a
Short Name:
TBIQOLHeadache
Description:
TBI-QOL Item Bank v1.0 - Headache Pain - Short Form 10a. Ten items are included. Tulsky, D. S., Kisala, P. A., Victorson, D., Carlozzi, N., Bushnik, T., Sherer, M., & Englander, J. (2016). TBI-QOL: development and calibration of item banks to measure patient reported outcomes following traumatic brain injury.The Journal of head trauma rehabilitation, 31(1), 40. TBI-QOL Items Copyright 2015 David Tulsky and Kessler Foundation. All rights reserved. http://www.assessmentcenter.net/ Recommended by CDISC for TBI
Disease:
Traumatic Brain Injury
Organization:
FITBIR
Required Program Form:
No
Standardization:
Standard NINDS CDE
Labels:
Form Type:
Clinical Assessment
Version:
1.0
Date Created:
2016-05-26
Owner:
Number of Data Elements:
28
eForms:
N

 Documentation


 Groups & Attached Data Elements

Logically grouped data elements with defined frequency at which they repeat.

# Title Short Description Variable Name Required? Type
1 GUID   Global Unique ID which uniquely identifies a subject GUID Required CDE
2 Subject identifier number   An identification number assigned to the participant/subject within a given protocol or a study. SubjectIDNum Optional CDE
3 Age in years   Value for participant's subject age recorded in years. AgeYrs Recommended CDE
4 Vital status   Status of participant/subject as alive or dead VitStatus Optional CDE
5 Visit date   Actual interview or visit date VisitDate Recommended CDE
6 Site name   The name of the site for the study SiteName Recommended CDE
7 Days since baseline   The number of days since baseline DaysSinceBaseline Optional CDE
8 Case control indicator   Indicator of whether subject is in the case or control arm of the study CaseContrlInd Optional CDE
9 General notes text   General notes GeneralNotesTxt Optional CDE

Additional Element Groups

Listed below are your additional element groups.

Form Administration (Appears Exactly 1 Time)

# Title Short Description Variable Name Required? Type
1 Language form administration ISO code  Code (ISO 639-2) for the language that was used for CRF/instrument/scale/etc. administration LangCRFAdministratISOCode Recommended CDE
2 Language form administration ISO code other text  The free-text field related to 'Language used for CRF/instrument/scale/etc. administration ISO code' specifying other text. LangCRFAdministratISOCodeOTH Recommended CDE
3 Context type  The context to which the questions were answered ContextType Recommended CDE
4 Context type other text  The free-text related to ContextType specifying other text ContextTypeOTH Recommended CDE
5 Data source  Source of the data provided on the case report form DataSource Recommended CDE
6 Data source other text  The free-text field related to Data source specifying other text. Source of the data provided on the case report form DataSourceOTH Recommended CDE

TBI-QOL Headache pain (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 TBI Quality of Life (TBI-QOL) - Irritable headache scale  The scale representing how often the participant was irritable because of headaches in the past 7 days, as part of Traumatic Brain Injury-Quality of Life (TBI-QOL). TBIQOLIrritableHeadacheScl Recommended CDE
2 TBI Quality of Life (TBI-QOL) - Interfere daily activities scale  The scale representing how often headaches interfered with the participant's daily activities in the past 7 days, as part of Traumatic Brain Injury-Quality of Life (TBI-QOL). TBIQOLInterfrDlyActivitiesScl Recommended CDE
3 TBI Quality of Life (TBI-QOL) - Constant pain scale  The scale which represents how often the participant had constant pain from headaches in the past 7 days, as part of Traumatic Brain Injury-Quality of Life (TBI-QOL). TBIQOLConstPainScl Recommended CDE
4 TBI Quality of Life (TBI-QOL) - Pounding sensation scale  The scale which represents how often the participant felt a pounding sensation in his/her head in the past 7 days, as part of Traumatic Brain Injury-Quality of Life (TBI-QOL). TBIQOLPoundingSenstnScl Recommended CDE
5 TBI Quality of Life (TBI-QOL) - Sharp pain scale  The scale which represents how often the participant felt sharp pains in his/her head in the past 7 days, as part of Traumatic Brain Injury-Quality of Life (TBI-QOL). TBIQOLSharpPainScl Recommended CDE
6 TBI Quality of Life (TBI-QOL) - Unable to concentrate scale  The scale which represents how often the participant was unable to concentrate because of headaches in the past 7 days, as part of Traumatic Brain Injury-Quality of Life (TBI-QOL). TBIQOLUnableToConcentrateScl Recommended CDE
7 TBI Quality of Life (TBI-QOL) - Carry on conversation scale  The scale which represents how often the participant felt a dull throbbing in my head in the past 7 days, as part of Traumatic Brain Injury-Quality of Life (TBI-QOL). TBIQOLDullThrobbingScl Recommended CDE
8 TBI Quality of Life (TBI-QOL) - Head hurt scale  The scale which represents how often the participant's head hurt in the past 7 days, as part of Traumatic Brain Injury-Quality of Life (TBI-QOL). TBIQOLHeadHurtScl Recommended CDE
9 TBI Quality of Life (TBI-QOL) - Headaches interfered with my ability scale  The scale which represents how often headaches interfered with the participant's ability to do things in the past 7 days, as part of Traumatic Brain Injury-Quality of Life (TBI-QOL). TBIQOLHdacheInterfrWMyAbScl Recommended CDE
10 TBI Quality of Life (TBI-QOL) - Bothered by headaches scale  The scale which represents how often the participant was bothered by headaches in the past 7 days, as part of Traumatic Brain Injury-Quality of Life (TBI-QOL). TBIQOLBothrByHdacheScl Recommended CDE

TBI-QOL Headache pain- scoring (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 TBI Quality of Life (TBI-QOL) - Headache raw score  The raw Score related to various aspects of headache pain, as part of the TBI Quality of Life (TBI-QOL). TBIQOLHeadacheRawScore Recommended CDE
2 TBI Quality of Life (TBI-QOL) - Headache T-score  The T-Score related to various aspects of headache pain including subjective experience of headache pain, as part of the TBI Quality of Life (TBI-QOL). TBIQOLHeadacheTScore Recommended CDE
3 TBI-Quality of Life (TBI-QOL) - Standard error  Standard error, as part of TBI-Quality of Life (TBI-QOL) measures TBIQOLStandardError Recommended CDE

 Change History

 Administrative Change History