Form Structure: TBI-QOL Item Bank v1.0 - Headache Pain - Short Form 10a
This form structure is an organized set of data definitions for a copyrighted form
			
			
		Resource:
							
								
									FITBIR
	    							
							
						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
							
						
					
						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 (a statistical measure of variance that represents the margin of error for the T-score), as part of TBI-Quality of Life (TBI-QOL) measures | TBIQOLStandardError | Recommended | CDE | 
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