CDE Detailed Report

Disease: Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage
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CDE ID CDE Name Variable Name Definition Short Description Question Text Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guidance) Subdomain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C01550 Temperature measurement anatomic site TempMeasrAntmicSite Anatomic site on or within the body where the temperature was measured Anatomic site on or within the body where the temperature was measure Temperature method Oral;Rectal;Tympanic;Axillary;Bladder;Esophageal;Brain;Other, specify Oral;Rectal;Tympanic;Axillary;Bladder;Esophageal;Brain;Other, specify Alphanumeric

Choose one

Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

3151195
C13517 Hand function findings result HandFuncFindReslt Assess hand function on the affected side using the Orgogozo Stroke Scale Assess hand function on the affected side using the Orgogozo Stroke Scale Hand function 15;10;5;0 Normal - No restriction upon the performance of any movement , even if there is a minimal weakness;Skilled - Restriction of fine movements. The more complex movements are impaired, but there is no restriction upon the performance of common, daily-life movements, even if these are executed slowly or clumsily , antagonistic movements between finger and thumb possible;Useful - Gross movements possible. Delicate movements cannot be performed, but patient can handle and carry objects of at least match-box size, use a fork or a pencil in approximate fashion, can handle a cane or grip a hand rail;Useless - Useful movements impossible. Patient cannot hold or carry objects, even if some elementary movements can be performed. Alphanumeric

(assessed by Orgogozo Stroke Scale) – Numeric scores may not be needed if the full Orgogozo Stroke Scale is not administered.

Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

C01003 Pupil reactivity light right eye result PupilReactivityLghtRtEyeReslt 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 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 Right pupil reactivity Sluggish;Nonreactive;Brisk;Untestable;Unknown Abnormal but still responsive;Abnormal;Normal;; Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

C18686 Hospital transport other text HospTrnsprtOTH The free-text field related to 'Hospital transport type' specifying other text. Type of transportation from injury scene to hospital The free-text field related to 'Hospital transport type' specifying other text. Type of transportation from injury scene to hospital Other, specify: Alphanumeric Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Pre-Hospital/Emergency Status [php] [php_1] 4000

Free-Form Entry

C01551 Respiration type RespTyp Type of respiration. Type of respiration. Respiration type Spontaneous;Ventilated;Apneic;Unknown;Mechanical ventilation Spontaneous;Ventilated;Apneic;Unknown;Mechanical ventilation Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

C13518 Upper limb tone findings result UpperLimTonFindReslt Assess tone of upper limbs on the affected side using the Orgogozo Stroke Scale Assess tone of upper limbs on the affected side using the Orgogozo Stroke Scale Upper limb tone 5;0 Normal - Near Normal. No frank hypertonia or hypotonia in comparison with the healthy side, even if the jerk reflexes are exaggerated;Overtly spastic or flaccid - Frank hypertonia or hypotonia in comparison with the healthy side. Permanent rigidity, or flexion or extension induced by painful stimuli. Numeric values

(assessed by Orgogozo Stroke Scale) – Numeric scores may not be needed if the full Orgogozo Stroke Scale is not administered.

Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

C01004 Pupil reactivity light left eye result PupilReactivityLghtLftEyeReslt 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 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 Left pupil reactivity Sluggish;Nonreactive;Brisk;Untestable;Unknown Abnormal but still responsive;Abnormal;Normal;; Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

C18747 Residence other text ResdncOTH The free-text field related to 'Residence type' specifying other text. Type of residence where the participant/subject is currently living The free-text field related to 'Residence type' specifying other text. Type of residence where the participant/subject is currently living Other, specify: Alphanumeric Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Pre-Hospital/Emergency Status [php] [php_1] 4000

Free-Form Entry

C01557 Respiratory support type RespSuppTyp Type of respiratory support participant/subject received Type of respiratory support participant/subject received Respiratory support type Bag mask ventilation (BMV);Intubation;CPAP;BiPAP;No support needed;Oral airway Bag mask ventilation (BMV);Intubation;CPAP (Continuous positive airway pressure);BiPAP (bilevel positive airway pressure);No support needed;Oral airway Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Pre-Hospital/Emergency Status [php] [php_1]

Multiple Pre-Defined Values Selected

C13519 Lower limb tone findings result LowerLimbToneFindgsReslt Assess tone of lower limbs on the affected side using the Orgogozo Stroke Scale Assess tone of lower limbs on the affected side using the Orgogozo Stroke Scale Lower limb tone 5;0 Normal - Near Normal. No frank hypertonia or hypotonia in comparison with the healthy side, even if the jerk reflexes are exaggerated;Overtly spastic or flaccid - Frank hypertonia or hypotonia in comparison with the healthy side. Permanent rigidity, or flexion or extension induced by painful stimuli. Numeric values

(assessed by Orgogozo Stroke Scale) – Numeric scores may not be needed if the full Orgogozo Stroke Scale is not administered.

Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

C01005 Pupil right eye measurement PupilRtEyeMeasr Measurement of the right pupil in millimeters Measurement of the right pupil in millimeters Right pupil measurement Numeric Values

mm

Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Pre-Hospital/Emergency Status [php] [php_1]

Free-Form Entry

1 10 millimeter
C18767 Temperature measurement other text TempMeasrOTH The free-text field related to 'Temperature measurement anatomic site' specifying other text. Anatomic site on or within the body where the temperature was measured The free-text field related to 'Temperature measurement anatomic site' specifying other text. Anatomic site on or within the body where the temperature was measure Other, specify: Alphanumeric Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Pre-Hospital/Emergency Status [php] [php_1] 4000

Free-Form Entry

3151195
C01565 Blood pressure systolic measurement BldPressrSystMeasr Measurement of pressure of the participant's blood against the artery walls during systole (the contraction phase) in millimeters of mercury (mmHg) Measurement of pressure of the participant's blood against the artery walls during systole (the contraction phase) in millimeters of mercury (mmHg) Blood pressure Numeric Values

BP in mmHg

Adult;Pediatric Supplemental 3.10 2024-03-11 10:40:09.0 Pre-Hospital/Emergency Status [php] [php_1]

Free-Form Entry

0 300 millimeter of mercury 2004289 C25298
C14204 Emergency Medical Services (EMS) vehicle type EMSVehicleTyp This refers to the Emergency Medical Services (EMS) vehicle that is used to transport the patient to the hospital. Choose one response This refers to the Emergency Medical Services (EMS) vehicle that is used to transport the patient to the hospital. Choose one respons Type of EMS vehicle Ground;Air;Other;Unknown;Mobile Stroke Unit Ground;Air;Other;Unknown;Mobile Stroke Unit Alphanumeric

Choose one.

No references available Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

C01006 Pupil left eye measurement PupilLftEyeMeasr Measurement of the left pupil in millimeters Measurement of the left pupil of the eye in mm Left pupil measurement Numeric Values

mm

Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Pre-Hospital/Emergency Status [php] [php_1]

Free-Form Entry

1 10 millimeter
C52564 Data source family relation specify text DataSourceFamRelSpecifyTxt Free-text field specifying the relationship of the family member from which data on the participant was obtained Free-text field specifying the relationship of the family member from which data on the participant was obtained Family, specify relation Alphanumeric Adult;Pediatric Supplemental 1.10 2024-02-29 15:42:33.0 Pre-Hospital/Emergency Status [php] [php_1] 255

Free-Form Entry

C01580 Temperature unit of measure TempUOM Unit of measure for the temperature numerical value Unit of measure for the temperature numerical value Temperature F;C degrees Fahrenheit;degrees Celsius Alphanumeric

Choose one. It is important to record whether the temperature is measured in degrees Celsius (°C) or degrees Fahrenheit (°F).It may also be important to record the location where the temperature measurement was made.

Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

2956267
C14205 Emergency Medical Services (EMS) scene arrival date and time EMSSceneArrvlDateTime This refers to the date/time when the Emergency Medical Services (EMS) vehicle arrives on the scene to transport the patient to the hospital This refers to the date/time when the Emergency Medical Services (EMS) vehicle arrives on the scene to transport the patient to the hospita Date and Time of EMS arrival at scene Date or Date & Time

This data element refers to the original scene and is not applicable to inter-facility transport or to patients arriving by means other than EMS. Note that EMS includes response by volunteer and professional paramedics, EMTs, fire, police and other municipal service officers responding to 911 calls. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

No references available Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Pre-Hospital/Emergency Status [php] [php_1]

Free-Form Entry

C01023 Pupil shape right eye type PupilShapeRtEyeTyp Type of shape of the pupil of the right eye Type of shape of the pupil of the right eye Right pupil shape Oval;Round;Unknown Oval;Round;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

C52740 Patient well last date and time PatientWellLastDateTime The date (and time, if known) the patient was last known to be well The date (and time, if known) the patient was last known to be well Date and time patient last known to be well Date or Date & Time

The purpose of this data element is to identify the earliest possible time that stroke symptoms began. This is sometimes known as "Onset Time" although the use of this term has been confusing to many in the past. If a patient experiences the onset of their symptoms in the company of another individual who can verify that the patient was functioning normally up until the time of start of symptoms, then in this patient the time "last known well" is also the time of symptom discovery. In many cases, however, no one is present at the exact start of symptoms. In this situation, we need to document the time when symptoms were first discovered (time of symptom discovery) as well as the time that the patient was last known to be well or at their baseline (time last known well), and record both of these. The time last known well should be the time closest to the time of discovery for which we have clear evidence that the patient was at their previous baseline. Depending on the type of symptoms, this might be established by a telephone or in person conversation. Family members, EMS personnel, and others, often mistakenly record the time of symptom discovery as the time the patient was last known well. It is imperative to distinguish these two times to avoid inappropriate use of IV t-PA (Intravenous Tissue Plasminogen Activator) in patients who are recently discovered to have symptoms but are many hours (>3 hrs) from their time of last being well.

Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Pre-Hospital/Emergency Status [php] [php_1]

Free-Form Entry

C04814 Residence type ResdncTyp Type of residence where the participant/subject is currently living Type of residence where the participant/subject is currently living Type of residence Hospital;Nursing home;Home;N/A - patient died;Other, specify;Unknown;Rehabilitation center Hospital;Nursing home;Home;N/A - patient died;Other, specify;Unknown;Rehabilitation center Alphanumeric

Choose one

Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

C14206 Emergency Medical Services (EMS) scene departure date and time EMSSceneDepartureDateTime Date and time the EMS vehicle departs with the patient from the scene to take the patient to the hospital Date and time the EMS vehicle departs with the patient from the scene to take the patient to the hospita Date and Time of EMS departure from scene Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

No references available Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Pre-Hospital/Emergency Status [php] [php_1]

Free-Form Entry

C01024 Pupil shape left eye type PupilShapeLftEyeTyp Type of shape of the pupil of the left eye Type of shape of the pupil of the left eye Left pupil shape Oval;Round;Unknown Oval;Round;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

C05404 Symptom onset date and time SymptmOnsetDateTime Date (and time, if applicable and known) reported for onset of participant's/subject's symptoms Date (and time, if applicable and known) reported for onset of participant's/subject's symptoms Date and time of discovery of first subarachnoid hemorrhage (SAH) symptom Date or Date & Time

This date and time should generally not vary between observers unless a witness noticed the onset of symptoms but did not alert anyone else, and a different individual is the one who contacted EMS or sought medical attention. If the event was witnessed, then the last known well date and time and the discovery date and time will be identical. Record both, even if identical. (To within 15 minutes of exact time of discovery is acceptable.)

Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Pre-Hospital/Emergency Status [php] [php_1]

Free-Form Entry

C14207 Pre-hospital stroke identification screen indicator PrehospStrokeIdScreenInd Whether a pre-hospital identification stroke screen was documented by EMS personnel. Pre-hospital stroke identification screens are defined as published validated screening algorithms or those required by state EMS agencies (e.g., LAPSS, CPSS, MASS, etc.) Whether a pre-hospital identification stroke screen was documented by EMS personnel. Pre-hospital stroke identification screens are defined as published validated screening algorithms or those required by state EMS agencies (e.g., LAPSS, CPSS, MASS, etc.) Was a pre-hospital identification stroke screen documented by EMS personnel Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. 'Unknown' means not documented or cannot be determined.

No references available Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

C01500 Airway treatment type AirwyTrtmtTyp Type of treatment or procedures the participant/subject received to support airway/ breathing Type of treatment or procedures the participant/subject received to support airway/ breathing Airway treatment type Supplemental oxygen;Adjunctive airway;Temporary support with bag, valve, mask;Intubation;Mechanical ventilation;Unknown;No specific treatment providing oxygen via nasal canula, oxygen mask or any other external oxygen source.;Examples are the mayo device, combitube or LME.;;;;;No specific treatment Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Pre-Hospital/Emergency Status [php] [php_1]

Multiple Pre-Defined Values Selected

C05418 Hospital transport type HospTrnsprtTyp Type of transportation from injury scene to hospital Type of transportation from injury scene to hospital Type of transport to hospital Ground ambulance with physician;Ground ambulance no physician;Private transportation/taxi/other from home/scene;By foot;Other, specify;Helicopter Ground ambulance with physician;Ground ambulance no physician;Private transportation/taxi/other from home/scene;By foot;Other, specify;Helicopter Alphanumeric

This refers to the method of transport to your hospital, not to the method of initial transport to another facility if the patient was subsequently transferred to your hospital.

Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

C14208 Pre-hospital neurological impairment scale indicator PrehospNeuroImpairScaleInd Whether a pre-hospital neurologic impairment scale screen was documented by EMS personnel. Pre-hospital neurologic impairment scales are defined as published validated scales or those required by state EMS agencies (e.g., GCS for suspected hemorrhagic stroke or any stroke with impaired consciousness, Los Angeles Motor Scale, etc.) Whether a pre-hospital neurologic impairment scale screen was documented by EMS personnel. Pre-hospital neurologic impairment scales are defined as published validated scales or those required by state EMS agencies (e.g., GCS for suspected hemorrhagic stroke or any stroke with impaired consciousness, Los Angeles Motor Scale, etc. Was a pre-hospital neurologic impairment screen documented by EMS personnel Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one

No references available Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

C01507 Blood pressure diastolic measurement BldPressrDiastlMeasr Measurement of pressure of the participant's blood against the artery walls during diastole (the relaxation phase) in millimeters of mercury (mmHg) Measurement of pressure of the participant's blood against the artery walls during diastole (the relaxation phase) in millimeters of mercury (mmHg) Blood pressure Numeric Values

BP in mmHg

Adult;Pediatric Supplemental 3.10 2024-03-11 10:40:54.0 Pre-Hospital/Emergency Status [php] [php_1]

Free-Form Entry

0 300 millimeter of mercury 2004291
C08147 Data source DataSource Source of the data provided on the case report form Source of the data provided on the case report form From whom/what were the medical history data obtained? Participant/subject;Mother;Father;Sister;Brother;Son;Daughter;Family, specify relation;Friend;Physician;Chart/Medical record;Other, specify;Unknown;Spouse Participant/subject;Mother;Father;Sister;Brother;Son;Daughter;Family, specify relation;Friend;Physician;Chart/Medical record;Other, specify;Unknown;Spouse Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-20 10:46:24.96 Pre-Hospital/Emergency Status [php] [php_1]

Multiple Pre-Defined Values Selected

C14223 Emergency Medical Services (EMS) service highest level type EMSServiceHighestLevelTyp Highest level of emergency medical service (EMS) provided Highest level of emergency medical service (EMS) provided Highest level of EMS service ALS;BLS;Flight nurse;MD;Paramedic;Unknown Advanced life support or equivalent;Basic life support or equivalent;;MD;Paramedic or equivalent;Unknown Alphanumeric

Choose one. BLS = Basic Life Support. ALS = Advanced Life Support. MD = physician

No references available Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

C01535 Respiratory rate RespRate Rate of the participant's breathing (inhalation and exhalation) Rate of the participant's breathing (inhalation and exhalation) Respiratory rate: Numeric Values

Breaths per minute

Adult;Pediatric Supplemental 3.10 2024-03-11 10:50:02.0 Pre-Hospital/Emergency Status [php] [php_1]

Free-Form Entry

0 120 breaths per minute 2644399
C10677 ZIP partial code ZIPPartialCode First three digits of the zip code where the participant/subject currently lives First three digits of the zip code where the participant/subject currently live First 3 digits of zip code Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Pre-Hospital/Emergency Status [php] [php_1] 255

Free-Form Entry

C00008 Age value AgeVal Value for participant's age, calculated as elapsed time since the birth of the participant Value for participant's age, calculated as elapsed time since the birth of the participant Age Numeric Values

years

Adult;Pediatric Supplemental 3.10 2024-02-29 15:47:28.0 Pre-Hospital/Emergency Status [php] [php_1]

Free-Form Entry

0 1800 month
C15910 Assessment date and time AssessDateTime The date of participant's injury The date of participant's injury Date and time assessment performed Date or Date & Time

Record the date to the level of precision known (e.g., month/day/year, year, month/year, etc). The preferred format for recording date is MM/DD/YYYY.

Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Pre-Hospital/Emergency Status [php] [php_1]

Free-Form Entry

C01539 Temperature measurement TempMeasr Measurement of the participant's/subject's body temperature Measurement of the participant's/subject's body temperatur Temperature Numeric Values

It is important to record whether the temperature is measured in degrees Celsius (°C) or degrees Fahrenheit (°F).It may also be important to record the location where the temperature measurement was made.

Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Pre-Hospital/Emergency Status [php] [php_1]

Free-Form Entry

0 50 degree Celsius 2644401
C13516 Hand strength findings result HandStrengthFindReslt Assess hand strength/ motor power on the affected side using the Scandinavian Stroke Scale Assess hand strength/ motor power on the affected side using the Scandinavian Stroke Scale Hand strength 6;4;2;0 Normal strength;Reduced strength in full range;Some movement, fingertips do not reach palm;Paralysis Numeric values

(assessed by Scandinavian Stroke Scale) – The points associated with the permissible values may be less relevant when the entire Scandinavian Stroke Scale is not being used.

Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

C00023 Hand preference type HandPrefTyp Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusively Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusivel Hand preference Left hand;Right hand;Both hands;Unknown Left hand;Right hand;Both hands;Unknown Alphanumeric

Choose one - the hand which the participant/subject uses predominantly, not necessarily the hand the participant/subject writes with exclusively.

Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Pre-Hospital/Emergency Status [php] [php_1]

Single Pre-Defined Value Selected

2180147
C18667 Data source other text DataSourcOTH The free-text field related to 'Data source' specifying other text. Source of the data provided on the case report form The free-text field related to 'Data source' specifying other text. Source of the data provided on the case report form Other, specify: Alphanumeric Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Pre-Hospital/Emergency Status [php] [php_1] 4000

Free-Form Entry

CSV