CDE Detailed Report

Disease: Stroke
Sub-Domain: History of Disease/Injury Event
CRF: Stroke Symptoms

Displaying 1 - 15 of 15
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (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 / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C14188 Neonatal level of consciousness type NeonatalLvlConsciousnTyp Type of abnormal level of consciousness of the neonate Type of abnormal level of consciousness of the neonate Describe level of consciousness Hyperalert;Lethargic;Stuporous/ Comatose Hyperalert;Lethargic;Stuporous/ Comatose Alphanumeric

Answer only if neonatal abnormal level of consciousness was reported as a stroke symptom/ comorbid event for the neonate.

International Pediatric Stroke Study (IPSS) Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Stroke Symptoms/Comorbid Events History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C14189 Neonatal encephalopathy level type NeonatalEncephalopLvlTyp Level of neonatal encephalopathy according to the Sarnat Staging Level of neonatal encephalopathy according to the Sarnat Staging Describe level of encephalopathy Mild Encephalopathy (Stage 1);Moderate Encephalopathy (Stage 2);Severe Encephalopathy (Stage 3) Hyperalertness, hyper-reflexia, dilated pupils, tachycardia, absence of seizures;Lethargy, hyper-reflexia, miosis, bradycardia, seizures, hypotonia with weak suck and Moro;Stupor, flaccidity, small to midposition pupils which react poorly to light, decreased stretch reflexes, hypothermia and absent Moro. Alphanumeric

Answer only if neonatal encephalopathy was reported as a stroke symptom/ comorbid event for the neonate.

Shankaran S, Laptook, AR, Ehrenkranz RA, et al. Whole-body hypothermia for neonates with hypotic-ischemic encephalopathy. The New England Journal of Medicine 2005; 353 (15): 1574-84. Sarnat HB, Sarnat MS. Neonatal encephalopathy following fetal distress: A clinical and electroencephalographic study. Archives of Neur. 1976;33:696-705. Finer N, Robertson C, Richards R, Pinnell L, Peters K. Hypoxic ischemic encephalopathy in term neonates: perinatal factors and outcome. Journal of Pediatrics 1981;98:112-7. Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Stroke Symptoms/Comorbid Events History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C14536 Seizure diagnosis method type SeizDiagnosMethdTyp Describes how the diagnosis of seizure was established. Describes how the diagnosis of seizure was established. How was the diagnosis of seizure established Clinical manifestations;EEG;Unknown Clinical manifestations;EEG;Not documented or Cannot be determined Alphanumeric

Answer only if seizure was reported as a stroke symptom/ comorbid event. Choose all that apply.

No references available Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Stroke Symptoms/Comorbid Events History of Disease/Injury Event Disease/Injury Related Events

Multiple Pre-Defined Values Selected

C14178 Stroke symptom/comorbid event type StrokSymCoTyp The symptom/ comorbid event experienced around the time of the stroke event The symptom/ comorbid event experienced around the time of the stroke event Stroke symptom/comorbid event Numbness or weakness of the face, arm or leg;Confusion, trouble speaking or understanding;Trouble seeing in one or both eyes;Trouble walking, dizziness, loss of balance or coordination;Headache;Seizure or convulsion;Vomiting;Other, specify Sudden numbness or weakness of the face, arm or leg, especially on one side of the body;;;;Sudden, severe headache with no known cause;;; Alphanumeric

Form associated with this CDE is about symptoms and comorbid events that the participant/ subject experienced around the time of the stroke event. (Examples of CDEs included: Stroke symptom/comorbid event type; Stroke symptom/comorbid event resolved at time of presentation; and Timing of Stroke symptom/comorbid event in relation to stroke onset)

The first five symptoms listed are from the American Heart Association's Stroke Warning Signs. Adult Supplemental 3.00 2013-06-21 00:00:00.0 Stroke Symptoms/Comorbid Events History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C14544 Pregnant or in postpartum period indicator PregPostpartPeriodInd Indicates if the female participant/subject is pregnant or postpartum. Postpartum is defined as giving birth less than 12 weeks ago. Indicates if the female participant/subject is pregnant or postpartum. Postpartum is defined as giving birth less than 12 weeks ago. Is she pregnant or in the postpartum period Yes;No;Unknown Yes;No;Unknown Alphanumeric

Answer only if the participant/subject is female.

HUPO Plasma Proteome Project specimen collection and handling: Towards the standardization of parameters for plasma proteome samples; Rai, A.J., Proteomics 2005, 5, 3262-3277. Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Stroke Symptoms/Comorbid Events History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C14179 Stroke symptom/comorbid event experienced indicator StrokSymCoEveExInd Indicates whether or not the symptom/ comorbid event was experienced around the time of the stroke event Indicates whether or not the symptom/ comorbid event was experienced around the time of the stroke event Experienced Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. If answered NO or UNKNOWN then 'Resolved at time of presentation', 'Date and time of resolution', 'Duration', and 'Timing in relation to stroke onset' should be left blank for the Stroke symptom/comorbid event.

No references available Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Stroke Symptoms/Comorbid Events History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C14545 Pregnant or in postpartum period status PregPostpartPeriodStatus The pregnancy or postpartum state. Postpartum is defined as giving birth less than 12 weeks ago. The pregnancy or postpartum state. Postpartum is defined as giving birth less than 12 weeks ago. Specify current state Pre-partum 1st trimester;Pre-partum 2nd trimester;Pre-partum 3rd trimester;Active labor;Postpartum first 24 hrs;Postpartum first week;Postpartum > 1 week Conception- 3 months;4-6 months;7-9 months;;;; Alphanumeric

Answer only if female participant/subject is pregnant or in postpartum state.

HUPO Plasma Proteome Project specimen collection and handling: Towards the standardization of parameters for plasma proteome samples; Rai, A.J., Proteomics 2005, 5, 3262-3277. Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Stroke Symptoms/Comorbid Events History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C14180 Stroke symptom/comorbid event resolve presentation indicator StrokSymCoEvResPresInd Indicates whether or not the symptom/ comorbid event had resolved at the time of stroke presentation Indicates whether or not the symptom/ comorbid event had resolved at the time of stroke presentation Resolved at time of presentation Yes;No;Unknown Yes;No;Unknown Alphanumeric

When date/time data are prepared for aggregation or sharing they should be converted to the format specified by ISO 8601, YYYY-MM-DDThh:mm:ss.

Get With The Guidelines (GWTG) Stroke Patient Management Tool Coding Instructions (Updated on 11/4/2009); Paul Coverdell National Acute Stroke Registry Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Stroke Symptoms/Comorbid Events History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C18905 Stroke symptom/comorbid event other text StrokSymCoOTH The free-text field related to 'Stroke symptom/comorbid event type' specifying other text. The symptom/ comorbid event experienced around the time of the stroke event The free-text field related to 'Stroke symptom/comorbid event type' specifying other text. The symptom/ comorbid event experienced around the time of the stroke event Other, specify Alphanumeric

Form associated with this CDE is about symptoms and comorbid events that the participant/ subject experienced around the time of the stroke event. (Examples of CDEs included: Stroke symptom/comorbid event type; Stroke symptom/comorbid event resolved at time of presentation; and Timing of Stroke symptom/comorbid event in relation to stroke onset)

The first five symptoms listed are from the American Heart Association's Stroke Warning Signs. Adult Supplemental 3.00 2013-06-21 00:00:00.0 Stroke Symptoms/Comorbid Events History of Disease/Injury Event Disease/Injury Related Events 4000

Free-Form Entry

C14181 Stroke symptom/comorbid event resolution date and time StrokSymCoEvReDateTime Date (and time, if applicable and known) the Stroke symptom/comorbid event resolved Date (and time, if applicable and known) the Stroke symptom/comorbid event resolved Date and Time of resolution 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 Stroke Symptoms/Comorbid Events History of Disease/Injury Event Disease/Injury Related Events

Free-Form Entry

C18906 Stroke symptom/comorbid event pediatric-specific other text StrokSymCoEvePedSpeOTH The free-text field related to 'Stroke symptom/comorbid event pediatric-specific type' specifying other text. The pediatric-specific symptom/ comorbid event experienced around the time of the stroke event The free-text field related to 'Stroke symptom/comorbid event pediatric-specific type' specifying other text. The pediatric-specific symptom/ comorbid event experienced around the time of the stroke event Other, specify Alphanumeric

Form associated with this CDE is about symptoms and comorbid events that the participant/ subject experienced around the time of the stroke event. (Examples of CDEs included: Stroke symptom/comorbid event type; Stroke symptom/comorbid event resolved at time of presentation; and Timing of Stroke symptom/comorbid event in relation to stroke onset)

International Pediatric Stroke Study (IPSS) Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Stroke Symptoms/Comorbid Events History of Disease/Injury Event Disease/Injury Related Events 4000

Free-Form Entry

C14182 Stroke symptom/comorbid event duration range StrokSymCoEveDurRng Approximate symptom duration. This is especially important if the diagnosis is Transient Ischemic Attack (TIA). Approximate symptom duration. This is especially important if the diagnosis is Transient Ischemic Attack (TIA). Duration <10 minutes;10 – 59 minutes;>= 60 minutes;Unknown <10 minutes;10 – 59 minutes;>= 60 minutes;Unknown Alphanumeric

Estimate the time of symptom duration for patients with transient neurological symptoms that are felt to be due to cerebral ischemia. When a range of time duration is provided in the record, choose the upper most limit. For example, if it states, "symptoms lasted between 5-20 minutes", then select "10-59 minutes" since 20 minutes would fall into the "10-59 minutes" range.

Get With The Guidelines (GWTG) Stroke Patient Management Tool Coding Instructions (Updated on 11/4/2009) Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Stroke Symptoms/Comorbid Events History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C14183 Stroke symptom/comorbid event timing in relation to stroke onset category StrokSymComrEvTimRelStrkOnsCat This element captures the time course of a comorbid symptom associated with the index stroke (examples of comorbid symptoms include: headache, vomiting, seizure, etc.). The element is intended to be recorded for each comorbid symptom separately. This element captures the time course of a comorbid symptom associated with the index stroke (examples of comorbid symptoms include: headache, vomiting, seizure, etc.). The element is intended to be recorded for each comorbid symptom separately. Timing in relation to stroke onset Preceded stroke onset by >= 24 hrs;Preceded stroke onset by >=6 but <24 hrs;Preceded stroke onset by <6 hrs;Onset coincident with stroke onset;Followed stroke onset by <6 hrs;Unknown Preceded stroke onset by >= 24 hrs;Preceded stroke onset by >=6 but <24 hrs;Preceded stroke onset by <6 hrs;Onset coincident with stroke onset;Followed stroke onset by <6 hrs;Unknown Alphanumeric

Choose one

No references available Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Stroke Symptoms/Comorbid Events History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C14184 Stroke symptom/comorbid event seizure type StrokSymComorEvSeizTyp The type of seizure experienced around the time of the stroke event The type of seizure experienced around the time of the stroke event Type of seizure Focal;Generalized;Epileptic Spasms;Unclassified seizure type Focal seizures include the following: Simple Partial, Seizures with Aura, Complex Partial;Generalized seizures include the following: Tonic Clonic, Absence, Myoclonic, Clonic, Tonic, Atonic;Epileptic spasm may be Focal, Generalized or Unclear; Alphanumeric

Answer only if seizure was reported as a Stroke symptom/comorbid event.

Berg, Anne T.; Berkovic, Samuel F.; Brodie, Martin J.; Buchhalter, Jeffrey; Cross, J. Helen; van Emde Boas, Walter; Engel, Jerome; French, Jacqueline; Glauser, Tracy A.; Mathern, Gary W.; Mosh&Eacute;, Solomon L.; Nordli, Douglas; Plouin, Perrine; Scheffer, Ingrid E. Revised terminology and concepts for organization of seizures and epilepsies: Report of the ILAE Commission on Classification and Terminology. Epilepsia, Volume 51, Number 4, April 2010 , pp. 676-685(10). Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Stroke Symptoms/Comorbid Events History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C14187 Stroke symptom/comorbid event pediatric-specific type StrokSymCoEvePedSpeTyp The pediatric-specific symptom/ comorbid event experienced around the time of the stroke event The pediatric-specific symptom/ comorbid event experienced around the time of the stroke event Stroke symptom/comorbid event Neonatal respiratory abnormalities;Neonatal poor feeding;Neonatal hypotonia;Neonatal abnormal level of consciousness.;Neonatal encephalopathy;Neonatal clinical seizure;Neonatal subclinical seizure;Other, specify Neonate exhibits difficulty maintaining respiration of presumed central origin. It includes apnea if not thought to be epileptic in etiology, otherwise code as seizures.;Neonate exhibits difficulty feeding of presumed central origin (either encephalopathy or true dysphagia), includes poor suck, regurgitation.;Neonate exhibits decreased muscle tone axial or appendicular.;;Clinical suspicion of neonatal encephalopathy should be considered in any infant exhibiting an abnormal level of consciousness, seizures, tone and reflex abnormalities, apnea, aspiration, feeding difficulties, and an abnormal hearing screen.;Neonate exhibits seizures with clinical manifestations (including apnea, if thought to be epileptic in etiology).;Neonate exhibits electrographic seizures without clinical manifestations (includes absence of clinical manifestations in the setting of pharmacologic paralysis).; Alphanumeric

Form associated with this CDE is about symptoms and comorbid events that the participant/ subject experienced around the time of the stroke event. (Examples of CDEs included: Stroke symptom/comorbid event type; Stroke symptom/comorbid event resolved at time of presentation; and Timing of Stroke symptom/comorbid event in relation to stroke onset)

International Pediatric Stroke Study (IPSS) Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Stroke Symptoms/Comorbid Events History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

CSV