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

 General Details

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:
No
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

 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 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

 Change History

 Administrative Change History