Form Structure: Second Insults and Other Complications
This form structure is an organized set of data definitions for a form that has not been copyrighted
Title:
Second Insults and Other Complications
Short Name:
SecInsultsOtherComplctns
Description:
Contains data elements that are collected to describe insults and complications the participant/subject experienced secondary to the injury.
Disease:
Traumatic Brain Injury
Organization:
NINDS
Required Program Form:
No
Standardization:
Standard NINDS CDE
Labels:
Form Type:
Clinical Assessment
Publication Date:
2019-03-11
Version:
1.0
Date Created:
2016-08-26
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 | Recommended | 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 | Recommended | CDE |
| 5 | Visit date | Actual interview or visit date | VisitDate | Recommended | CDE |
| 6 | Site name | The name of the site for the study | SiteName | Optional | 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 Adminstration (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 |
Second Insults and Other Complications (Appears Up To 1 Time)
| # | Title | Short Description | Variable Name | Required? | Type |
|---|---|---|---|---|---|
| 1 | 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 |
| 2 | 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 |
| 3 | Cardiac arrest indicator | Indicator of cardiac arrest requiring cardiopulmonary resuscitation (i.e. at least two minutes of chest compressions). Cardiac arrest is a condition in which the heart suddenly and unexpectedly stops beating | CardArrestInd | Recommended | CDE |
| 4 | Seizure indicator | Indicator of seizure activity | SeizInd | Recommended | CDE |
| 5 | Seizure presentation type | Type of seizure activity as convulsive or non-convulsive (diagnosed on EEG only, no motor manifestations) | SeizPresentTyp | Recommended | CDE |
Additional Supplemental Elements (Appears Up To 1 Time)
| # | Title | Short Description | Variable Name | Required? | Type |
|---|---|---|---|---|---|
| 1 | Hypertension indicator | Indicator of hypertension. In adults, hypertension is defined as a systolic pressure >= 140 and a diastolic >= 90. In children, it is defined as systolic blood pressure >95th percentile for age | HypertensInd | Optional | CDE |
| 2 | Hypothermia indicator | Indicator of hypothermia. Hypothermia is defined as core temperature 35 degrees Celsius | HypothermInd | Optional | CDE |
| 3 | Hyperthermia indicator | Indicator of hyperthermia. Hyperthermia is defined as core temperature > 38 degrees Celsius | HyperthermInd | Optional | CDE |
| 4 | Inadvertent hypocapnia indicator | Indicator of inadvertent hypocapnia episode. Inadvertent hypocapnia is defined as the partial pressure of carbon dioxide in the blood (paCo2) <= 25 mmHg (3.3 kPa), not deliberately employed to treat elevated intracranial pressure | InadvertHypocapniaInd | Optional | CDE |
| 5 | Seizure duration type | Seizure described as intermittent or status epilepticus. Status epilepticus is defined as either 2 or more convulsions without complete recovery of consciousness between seizures or as a single prolonged seizure that lasts for at least 30 minutes. | SeizDurType | Optional | CDE |
| 6 | EEG monitoring type | Type of electroencephalogram (EEG) monitoring | EEGMonitorType | Optional | CDE |
| 7 | Hyperventilation indicator | Indicator of hyperventilation. Hyperventilation is defined as rapid, deep breathing, possibly exceeding 40 breaths/minute | HyperventInd | Optional | CDE |
| 8 | Aspiration indicator | Indicator of foreign material breathed into the airway | AspiratnInd | Optional | CDE |
Keywords
