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Form Structure: TBI-QOL Item Bank v1.0 - Anxiety - Short Form 10a

This form structure is an organized set of data definitions for a copyrighted form
Title:
TBI-QOL Item Bank v1.0 - Anxiety - Short Form 10a
Short Name:
TBIQOLAnxiety
Description:
The TBI-QOL item pools for Anxiety was made up primarily of PROMIS items for Anxiety. There are 10 items 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:
NIH/CIT/BRICS
Required Program Form:
No
Standardization:
Standard NINDS CDE
Labels:
Form Type:
Clinical Assessment
Publication Date:
2016-12-14
Version:
1.1
Date Created:
2016-05-27
Owner:
Number of Data Elements:
26
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.

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Form Administration (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Context type  The context to which the questions were answered ContextType Recommended CDE
2 Context type other text  The free-text related to ContextType specifying other text ContextTypeOTH Recommended CDE
3 Data source  Source of the data provided on the case report form DataSource Recommended CDE
4 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 Anxiety (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Patient-Reported Outcome Measurement Information System (PROMIS) - feel uneasy past week scale  The scale which represents how often the participant felt uneasy in the past 7 days, as part of the Patient-Reported Outcome Measurement Information System (PROMIS). PROMISFeltUneasyScale Recommended CDE
2 Patient-Reported Outcome Measurement Information System (PROMIS) - feel nervous past week scale  The scale which represents how often the participant felt nervous in the past 7 days, as part of the Patient-Reported Outcome Measurement Information System (PROMIS). PROMISFeltNervousScale Recommended CDE
3 Patient-Reported Outcome Measurement Information System (PROMIS) - feel something awful would happen past week scale  The scale which represents how often the participant felt something awful would happen in the past 7 days, as part of the Patient-Reported Outcome Measurement Information System (PROMIS). PROMISSomethingAwflHappenScale Recommended CDE
4 Patient-Reported Outcome Measurement Information System (PROMIS) - feel terrified past week scale  The scale which represents how often the participant felt terrified in the past 7 days, as part of the Patient-Reported Outcome Measurement Information System (PROMIS). PROMISFeltTerrifiedScale Recommended CDE
5 Patient-Reported Outcome Measurement Information System (PROMIS) - feel tense past week scale  The scale which represents how often the participant felt tense in the past 7 days, as part of the Patient-Reported Outcome Measurement Information System (PROMIS). PROMISFeltTenseScale Recommended CDE
6 Patient-Reported Outcome Measurement Information System (PROMIS) - many situations made worry past week scale  The scale which represents how often many situations made the participant worry in the past 7 days, as part of the Patient-Reported Outcome Measurement Information System (PROMIS). PROMISManySitsMadeWorryScale Recommended CDE
7 Patient-Reported Outcome Measurement Information System (PROMIS) - sudden feelings panic past week scale  The scale which represents how often the participant had sudden feelings of panic in the past 7 days, as part of the Patient-Reported Outcome Measurement Information System (PROMIS). PROMISSuddenFeelingsOfPncScale Recommended CDE
8 Patient-Reported Outcome Measurement Information System (PROMIS) - difficult calm down past week scale  The scale which represents how often the participant had difficulty calming down in the past 7 days, as part of the Patient-Reported Outcome Measurement Information System (PROMIS). PROMISDifficultyCalmDownScale Recommended CDE
9 Patient-Reported Outcome Measurement Information System (PROMIS) - racing pounding heart past week scale  The scale which represents how often the participant had a racing or pounding heart in the past 7 days, as part of the Patient-Reported Outcome Measurement Information System (PROMIS). PROMISRacePoundHeartScale Recommended CDE
10 Patient-Reported Outcome Measurement Information System (PROMIS) - feel need help with anxiety past week scale  The scale which represents how often the participant felt like help was needed for his anxiety in the past 7 days, as part of the Patient-Reported Outcome Measurement Information System (PROMIS). PROMISFltHlpNeedFrAnxietyScale Recommended CDE

TBI-QOL Anxiety- scoring (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 TBI Quality of Life (TBI-QOL) - Anxiety raw score  Raw score of anxiety, as part of TBI-QOL. TBIQOLAnxietyRawScore Recommended CDE
2 TBI Quality of Life (TBI-QOL) - Anxiety T-score  The T-Score related to symptoms that reflect autonomic arousal and experience of threat, including self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal, and somatic symptoms related to arousal. TBIQOLAnxietyTScore 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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