Form Structure: FITBIR Vital Signs
This form structure is an organized set of data definitions for a form that has not been copyrighted
Title:
FITBIR Vital Signs
Short Name:
VitalSigns_FITBIR
Description:
A comprehensive set of Vital Signs CDEs, collects subject heart rate, respiratory rate, blood pressure, temperature, weight, and height. This form structure was created based on recommendations from NINDS - https://www.commondataelements.ninds.nih.gov/General.aspx#tab=Data_Standards
Disease:
General (For all diseases)
Organization:
NIH
Required Program Form:
Yes
Standardization:
Standard NINDS CDE
Labels:
Form Type:
Clinical Assessment
Publication Date:
2017-07-28
Version:
1.1
Date Created:
2016-03-29
Owner:
Number of Data Elements:
66
eForms:
Y
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 | Optional | CDE |
| 5 | Site name | The name of the site for the study | SiteName | Recommended | CDE |
| 6 | Days since baseline | The number of days since baseline | DaysSinceBaseline | Recommended | CDE |
| 7 | Case control indicator | Indicator of whether subject is in the case or control arm of the study. | CaseContrlInd | Recommended | CDE |
| 8 | General notes text | General notes | GeneralNotesTxt | Recommended | 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 |
Vital Signs (Appears Up To 1 Time)
| # | Title | Short Description | Variable Name | Required? | Type |
|---|---|---|---|---|---|
| 1 | Vital signs date and time | Date (and time, if applicable and known) the vital signs and other body measurements were taken by indicating the month, day, and year for the date and am, pm, or 24 hour clock for time | VitalSgnDateTime | Recommended | CDE |
| 2 | Heart rate | The participant/subject's pulse or number of contractions (heart beats) per minute | HeartRate | Recommended | CDE |
| 3 | Respiratory rate | Rate of the participant/subject's breathing (inhalation and exhalation). | RespRate | Recommended | CDE |
| 4 | Temperature measurement | Measurement of the participant's/subject's body temperature. | TempMeasr | Recommended | CDE |
| 5 | Temperature maximum daily measurement | Measurement of the participant's/ subject's highest temperature over a 24-hour period | TempMaxDailyMeasr | Recommended | CDE |
| 6 | Temperature measurement anatomic site | Anatomic site on or within the body where the temperature was measured. | TempMeasrAntmicSite | Recommended | CDE |
| 7 | Weight measurement | Measurement of participant's/subject's weight | WgtMeasr | Recommended | CDE |
| 8 | Weight unit of measure | Unit of measure for the weight numerical value | WgtUoM | Optional | CDE |
| 9 | Height measurement | Measurement of participant's/subject's height. | HgtMeasr | Recommended | CDE |
| 10 | Height unit of measure | Unit of measure for the height numerical value for subject/participant | HgtUOM | Optional | CDE |
| 11 | Body mass index value | Value of the participant/subject's body mass index, calculated from height and weight. | BMIVal | Optional | CDE |
| 12 | Head circumference measurement | Circumferential measurement of the head at the widest point - the distance from above the eyebrows and ears and around the back of the head | HeadCircumfMeasr | Recommended | CDE |
| 13 | Head circumference unit of measure | Unit of measure for the head circumference numerical value | HdCircumfUoM | Optional | CDE |
| 14 | Height or length alternative measurement | Measurement of height or length of subject/participant when unable to stand | HgtLgnthAltMeasr | Optional | CDE |
| 15 | Height or length alternative unit of measure | Unit of measure for the height or length numerical value for subject/participant | HgtLngthAltUoM | Optional | CDE |
| 16 | Hip circumference measurement | A measurement of the body circumference at the level of the hip. It should be the hip circumference at its widest part of the buttocks or hip. | HipCircumMeasr | Optional | CDE |
| 17 | Hip circumference unit of measure | Units used to measure the hip circumference. | HipCircumUoM | Optional | CDE |
| 18 | Waist circumference measurement | A measurement of the body circumference at the level of the waist. It should be the smallest circumference of the natural waist, usually just above the belly button. | WaitCirMeasr | Optional | CDE |
| 19 | Waist circumference measurement unit of measure | Units used to calculate waist participant/subject's hip circumference | WstCircumfMeasrUnit | Optional | CDE |
| 20 | Weight to height ratio value | Ratio of participant/subject's weight to height | WgtHgtRatioVal | Optional | CDE |
Blood Pressure (Appears Up To 1 Time)
| # | Title | Short Description | Variable Name | Required? | Type |
|---|---|---|---|---|---|
| 1 | Blood pressure measurement position type | Indicator of the participant/subject's position during the blood pressure measurement. | BldPressrMeasrPositionTyp | Recommended | CDE |
| 2 | Blood pressure systolic measurement | Measurement of pressure of the participant's/subject's blood against the artery walls during systole (the contraction phase) in millimeters of mercury (mmHg) | BldPressrSystMeasr | Recommended | CDE |
| 3 | Blood pressure diastolic measurement | Measurement of pressure of the participant's/subject's blood against the artery walls during diastole (the relaxation phase) in millimeters of mercury (mmHg) | BldPressrDiastlMeasr | Recommended | CDE |
Blood gasses (Appears Up To 1 Time)
| # | Title | Short Description | Variable Name | Required? | Type |
|---|---|---|---|---|---|
| 1 | Arterial partial pressure oxygen value | Measurement of how much oxygen is dissolved in the arterial blood and how well oxygen is able to move from the airspace of the lungs into the blood (PaO2) | ArterialPPO2Val | Recommended | CDE |
| 2 | Arterial partial pressure oxygen mean daily value | Mean measurement of the partial pressure of oxygen (PaO2) over a 24-hour period. PaO2 is the pressure of oxygen dissolved in the blood and how well oxygen is able to move from the airspace of the lungs into the blood. | ArterialPPO2MeanDailyVal | Recommended | CDE |
| 3 | Arterial partial pressure carbon dioxide value | Measurement of how much carbon dioxide is dissolved in the arterial blood and how well carbon dioxide is able to move out of the body (PaCO2) | ArterialPPCO2Val | Recommended | CDE |
| 4 | Arterial partial pressure carbon dioxide mean daily value | Mean measurement of the arterial partial pressure of carbon dioxide (PCO2) over a 24-hour period. PCO2 is the measurement of how much carbon dioxide is dissolved in the arterial blood and how well carbon dioxide is able to move out of the body. | ArterialPPCO2MeanDailyVal | Recommended | CDE |
| 5 | Oxygen saturation minimum daily value | Lowest measurement of the participant's/subject's oxygen saturation over the 24-hour period. | O2SaturMinDailyVal | Recommended | CDE |
| 6 | Oxygen saturation mean daily measurement | Value of the mean of the participant's/subject's oxygen saturation over a 24-hour period. | O2SaturMeanDailyMeasr | Recommended | CDE |
| 7 | Pulmonary gas exchange oxygen saturation value | The result of the SpO2 check | PulmGasExchngO2SaturVal | Recommended | CDE |
| 8 | Pulmonary gas exchange lowest oxygen saturation value | The lowest recorded oxygen saturation (SpO2) value while sleeping the participant/subject is sleeping | PulmGasExchLowstO2SaturVal | Recommended | CDE |
| 9 | Oxygen saturation measurement | Value, as a percent, of baseline O2 saturation (SPO2) in nocturnal oximetry, as part of Nocturnal Oximetry. | O2SatMeasr | Recommended | CDE |
| 10 | Partial pressure oxygen brain tissue measurement | Measurement of how much oxygen is dissolved in the brain tissue (PbtO2) | PPO2BrainTissMeasr | Recommended | CDE |
ICP (Appears Up To 1 Time)
| # | Title | Short Description | Variable Name | Required? | Type |
|---|---|---|---|---|---|
| 1 | ICP Catheter indicator | Indicates use of ICP catheter | ICPCathetrInd | Recommended | UDE |
| 2 | Intracranial pressure catheter anatomic site | Anatomic site where the intracranial pressure (ICP) catheter is implanted in the participant/subject | ICPCathetrAntmicSite | Recommended | CDE |
| 3 | Intracranial pressure catheter other text | The free-text field related to 'Intracranial pressure catheter anatomic site' specifying other text. Anatomic site where the intracranial pressure (ICP) catheter is implanted in the participant/subject | ICPCathetrOTH | Recommended | CDE |
| 4 | Intracranial pressure monitoring start date and time | Date (and time, if applicable and known) the intracranial pressure (ICP) monitoring began | ICPMonitorStartDateTime | Recommended | CDE |
| 5 | Intracranial pressure monitoring stop date and time | Date (and time, if applicable and known) the intracranial pressure (ICP) catheter was removed from the participant/subject and the ICP monitoring was stopped | ICPMonitorStopDateTime | Recommended | CDE |
| 6 | Intracranial pressure measurement | Measurement of intracranial pressure (ICP), the amount of pressure that the cranium exerts on brain tissue, the brain's blood volume, and cerebrospinal fluid | ICPMeasr | Recommended | CDE |
| 7 | Intracranial pressure maximum daily measurement | Highest measurement of the participant's/ subject's intracranial pressure (ICP) in mmHg over the 24-hour period | ICPMaxDailyMeasr | Recommended | CDE |
| 8 | Intracranial pressure mean daily measurement | Mean measurement of the participant's/ subject's intracranial pressure (ICP) in mmHg over the 24-hour period | ICPMeanDailyMeasr | Recommended | CDE |
| 9 | Intracranial pressure monitoring stopped reason | Primary reason the intracranial pressure (ICP) monitoring of the participant/subject was stopped | ICPMonitorStopRsn | Recommended | CDE |
| 10 | Intracranial pressure catheter revised indicator | Indicator of whether the intracranial pressure (ICP) catheter was revised due to problems with ICP monitoring which may lead to inaccurate (interpretation of measured values. | ICPCathetrReviseInd | Recommended | CDE |
| 11 | Intracranial pressure monitoring problem type | Type of problem experienced when monitoring the participants/subjects intracranial pressure (ICP) which may lead to inaccurate interpretation of measured values. | ICPMonitorProbType | Recommended | CDE |
| 12 | Intracranial pressure monitoring problem other text | Free-text field to 'Intracranial pressure monitoring problem type' specifying other text. Type of problem experienced when monitoring the participant's/subject's intracranial pressure (ICP) which may lead to inaccurate interpretation of measured values. | ICPMonitorProbOTH | Recommended | CDE |
| 13 | Intracranial pressure episode greater 20 mmHg longer 5 minutes number | Number of episodes where the participant's/subject's intracranial pressure was greater than 20 mmHg lasting for longer than five minutes | ICPEps20mmHG5MinDurNum | Recommended | CDE |
| 14 | Intracranial pressure episode greater 20 mmHg number | Number of episodes where the participant's/subject's intracranial pressure was greater than 20 mmHg | ICPEpisodOver20mmHgNum | Recommended | CDE |
Cerebral perfusion pressure (Appears Up To 1 Time)
| # | Title | Short Description | Variable Name | Required? | Type |
|---|---|---|---|---|---|
| 1 | Cerebral perfusion pressure value | Value of the difference between the Mean Arterial Pressure (MAP) and the Intracranial Pressure (ICP). It represents the pressure gradient driving cerebral blood flow and hence oxygen and metabolite delivery. | CerebrlPerfusPressrVal | Recommended | CDE |
| 2 | Cerebral perfusion pressure episodes lower 60 mmHg number | Number of episodes of critical cerebral perfusion pressure less than 60 mmHg | CerbrlPerfsnPrsrEpLwr60mmHgNum | Recommended | CDE |
Circulation and respiratory (Appears Up To 1 Time)
| # | Title | Short Description | Variable Name | Required? | Type |
|---|---|---|---|---|---|
| 1 | Circulation support type | Therapies or procedures the participant/subject received to support circulation | CircSuppTyp | Recommended | CDE |
| 2 | Respiration type | Type of respiration. This is especially relevant to collect at the time respiratory rate is measured. | RespTyp | Recommended | CDE |
| 3 | Respiratory support type | Type of respiratory support participant/subject received | RespSuppTyp | Recommended | CDE |
Keywords
