Form Structure: Baseline Risk Assessment
This form structure is an organized set of data definitions for a form that has not been copyrighted
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
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 indicator | Indicator 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 |
Keywords
