This form structure is an organized set of data definitions for a form that has not been copyrighted

 General Details

Title:
Baseline Risk Assessment
Short Name:
BRA
Description:
This module is a risk assessment for mortality or unfavorable outcome following traumatic brain injury expressed as fraction or percentage. It contains data elements that can be derived or pulled from other CRF modules and modified in a format to be entered into the prognostic model. The IMPACT prognostic model is used for moderate and severe TBI and the model proposed by CRASH trial is used for mild TBI.
Disease:
Traumatic Brain Injury
Organization:
NINDS
Required Program Form:
No
Standardization:
Standard NINDS CDE
Labels:
Form Type:
Clinical Assessment
Version:
1.0
Date Created:
2016-02-22
Owner:
Number of Data Elements:
27
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 Up To 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
7 BRICS data completeness index  Index reflecting the completeness of data in BRICS calculated for a given row as % of missing variables. Calculated in % BRICSDataCompletIndex Optional CDE
8 Data captured by type  Type of an individual (or a device) who captured the subject data and/or filled out the case report form (CRF), questionnaire, assessment form, computerized test, etc., including eFORMs and automatic sensors DataCapturedByTyp Recommended CDE
9 Data captured by other text  The free-text field related to "Data captured by whom type" specifying other text DataCapturedByTypOTH Optional CDE

Baseline Risk Assessment (Repeat Infinitely)

# Title Short Description Variable Name Required? Type
1 Hypoxic episode indicator  Indicator of hypoxic episode. Hypoxic episode is defined as partial pressure of oxygen in the blood (paO2) less than 8kPa (60mmHg) or oxygen saturation (SaO2) less than 90% HypxEpiInd Recommended CDE
2 Hypotensive episode indicator  Indicator of hypotensive episode. In adults, hypotensive episode is defined as systolic blood pressure & less than ; 90 mmHg. In children, it is defined as systolic blood pressure & less than ; 5th percentile for age HypotnsnEpiInd Recommended CDE
3 Pupil reactivity light left eye result  Result of testing of the contraction of the participant's/subject's left pupil when a bright light is shone on it from an angle PupilReactivityLghtLftEyeReslt Recommended CDE
4 Pupil reactivity light right eye result  Result of testing of the contraction of the participant's/subject's right pupil when a bright light is shone on it from an angle PupilReactivityLghtRtEyeReslt Recommended CDE
5 Subarachnoid hemorrhage status  Status of macroscopic blood located between the brain surface and the arachnoid membrane. On CT and MR, the blood in this location will follow the contour of the sulci and cisterns. Acute SAH is hyperdense on CT and hyperintense on FLAIR MR imaging. SAHStatus Recommended CDE
6 Marshall CT classification code  Code for Marshall CT classification MrshlCTClassCode Recommended CDE
7 Glasgow Coma Scale (GCS) - Motor response scale  Glasgow Coma Scale (GCS) - Best motor response (M). The GCS is a standardized instrument for assessing the level of consciousness. It evaluates three aspects of responsiveness: eye opening, motor response, verbal response. GCSMotorRespnsScale Recommended CDE
8 Pediatric Glasgow Coma Scale (PGCS) - Motor response score  Score for the participant's motor response according to the Pediatric Glasgow Coma Scale (PGCS) if the participant is under the age of 18. PGCSMotorRespnsScore Recommended CDE
9 Sedation status  Status of sedation of the participant/subject SedationStatus Recommended CDE

 Change History

 Administrative Change History