CDE Detailed Report

Disease: content
Subdomain Name: Classification
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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
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

For children younger than one year born at less than 36 weeks gestation, it is recommended to also collect gestational age. Recording date of birth will give the most detailed information required for calculation of age and is recommended as first choice. However, in some studies recording date of birth may elicit discussions on a potential violation of privacy legislation and specifically HIPAA regulations. In these cases, the calculated age should be recorded.

Steyerberg EW, Mushkudiani N, Perel P, et al. Predicting outcome after traumatic brain injury: development and international validation of prognostic scores based on admission characteristics. PLoS Med. Aug 2008;5(8):e165. MRC CRASH Trial Collaborators. Predicting outcome after traumatic brain injury: practical prognostic models based on large cohort of international patients. BMJ. Feb 2008;336(7641):425-429. Pediatric-specific reference(s): Anderson V, Catroppa C, Morse S, Haritou F, Rosenfeld J (2005) Functional plasticity or vulnerability after early brain injury. Pediatrics 116:1374-1382 Adult;Pediatric Supplemental 3.10 2024-02-29 15:47:28.0 Baseline Risk Assessment Classification Disease/Injury Related Events

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0 1800 month
C01001 Glasgow Coma Scale (GCS) - motor response scale GCSMotorRespnsScale Glasgow Coma Scale (GCS) - Best motor response (M). The GCS is a standardized instrument for assessing the level of consciousness. It evaluates three aspects of responsiveness: eye opening, motor response, verbal response Glasgow Coma Scale (GCS) - Best motor response (M). The GCS is a standardized instrument for assessing the level of consciousness. It evaluates three aspects of responsiveness: eye opening, motor response, verbal respons Motor response 1;2;3;4;5;6;Untestable;Unknown No motor response;Abnormal extension/Extensor response;Abnormal flexion;Flexion withdrawal/withdraws from pain;Localizes pain;Obeys command;Untestable;Unknown Numeric Values

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Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. Jul 1974;2(7872):81-4. Marmarou A, Lu J, Butcher I, et al. Prognostic value of the Glasgow Coma Scale and pupil reactivity in traumatic brain injury assessed pre-hospital and on enrollment: an IMPACT analysis. J Neurotrauma. Feb 2007;24(2):270-80. Stocchetti N, Pagan F, Calappi E, et al. Inaccurate early assessment of neurological severity in head injury. J Neurotrauma. Sep 2004:21(9):1131-40. Balestreri M, Czosnyka M, Chatfield DA, et al. Predictive value of Glasgow Coma Scale after brain trauma: change in trend over the past ten years. J Neurol Neurosurg Psychiatry. Jan 2004;75(1):161-2. Steyerberg EW, Mushkudiani N, Perel P, et al. Predicting outcome after traumatic brain injury: development and international validation of prognostic scores based on admission characteristics. PLoS Med. Aug 2008;5(8):e165. MRC CRASH Trial Collaborators. Predicting outcome after traumatic brain injury: practical prognostic models based on large cohort of international patients. BMJ. Feb 2008;336(7641):425-429. Adult;Pediatric Core 3.00 2013-07-20 10:21:25.65 Baseline Risk Assessment Classification Disease/Injury Related Events

Single Pre-Defined Value Selected

C124725
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

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Marmarou A, Lu J, Butcher I, et al. Prognostic value of the Glasgow Coma Scale and pupil reactivity in traumatic brain injury assessed pre-hospital and on enrollment: an IMPACT analysis. J Neurotrauma. Feb 2007;24(2):270-80. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Baseline Risk Assessment Classification Disease/Injury Related Events

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

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Marmarou A, Lu J, Butcher I, et al. Prognostic value of the Glasgow Coma Scale and pupil reactivity in traumatic brain injury assessed pre-hospital and on enrollment: an IMPACT analysis. J Neurotrauma. Feb 2007;24(2):270-80. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Baseline Risk Assessment Classification Disease/Injury Related Events

Single Pre-Defined Value Selected

C01007 Sedation status SedationStatus Status of sedation of the participant/subject Status of sedation of the participant/subject Sedation No sedation/paralysis;After stopping sedation;After pharmacologic reversal;Under sedation No sedation/paralysis;After stopping sedation;After pharmacologic reversal;Under sedation Alphanumeric

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Steyerberg EW, Mushkudiani N, Perel P, et al. Predicting outcome after traumatic brain injury: development and international validation of prognostic scores based on admission characteristics. PLoS Med. Aug 2008;5(8):e165. MRC CRASH Trial Collaborators. Predicting outcome after traumatic brain injury: practical prognostic models based on large cohort of international patients. BMJ. Feb 2008;336(7641):425-429. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Baseline Risk Assessment Classification Disease/Injury Related Events

Single Pre-Defined Value Selected

C01021 Pediatric Glasgow Coma Scale (PGCS) - motor response score PGCSMotorRespnsScore Score for the participant's motor response according to the Pediatric Glasgow Coma Scale (PGCS) if the participant is under the age of 18 Score for the participant's motor response according to the Pediatric Glasgow Coma Scale (PGCS) if the participant is under the age of 1 Motor response 1;2;3;4;5;6;Untestable;Unknown No motor response;Extension to pain;Flexion to pain;Withdrawal from pain;Localizing pain;Obeys commands;Untestable;Unknown Alphanumeric

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Marcin J and Pollack M. (2002). Triage scoring systems, severity of illness measures, and mortality prediction models in pediatric trauma. Crit Care Med. 30:S457-S467. Pediatric Core 3.00 2013-07-20 10:21:25.65 Baseline Risk Assessment Classification Disease/Injury Related Events

Single Pre-Defined Value Selected

C02469 Subarachnoid hemorrhage indicator SAHStatus Indicator of macroscopic blood located between the brain surface and the arachnoid membrane. On CT and MR, the blood in this location will follow the contour of the sulci and cisterns. Acute SAH is hyperdense on CT and hyperintense on FLAIR MR imaging Indicator of macroscopic blood located between the brain surface and the arachnoid membrane. On CT and MR, the blood in this location will follow the contour of the sulci and cisterns. Acute SAH is hyperdense on CT and hyperintense on FLAIR MR imaging Subarachnoid hemorrhage Present;Absent;Indeterminate Present;Absent;Indeterminate Alphanumeric

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Duhaime AC, Gean AD, Haacke EM, Hicks R, Wintermark M, Mukherjee P, Brody D, Latour L, Riedy G; Common Data Elements Neuroimaging Working Group Members, Pediatric Working Group Members. Common data elements in radiologic imaging of traumatic brain injury. Arch Phys Med Rehabil. 2010 Nov;91(11):1661-6. [DOI: 10.1016/j.apmr.2010.07.238] Haacke, E.M., Duhaime, A.C., Gean, A.D., Riedy, G., Wintermark, M., Mukherjee, P., Brody, D.L., DeGraba, T., Duncan, T.D., and Elovic, E. (2010). Common data elements in radiologic imaging of traumatic brain injury. Journal of Magnetic Resonance Imaging 32, 516-543, DOI:10.1002/jmri.22259 Adult;Pediatric Core 3.10 2022-09-08 09:18:39.0 Baseline Risk Assessment Classification Disease/Injury Related Events

Single Pre-Defined Value Selected

C02505 Marshall CT classification code MrshlCTClassCode Code for Marshall CT classification Code for Marshall CT classification 2;4;5;1;3 Diffuse injury: Cisterns present with shift 0-5 mm, lesions present, but no high or mixed density lesion >25 cc. May include bone fragments and foreign bodies;Diffuse injury with shift: Shift >5 mm, no high or mixed density lesion >25 cc.;Mass lesions: High or mixed density lesion > 25cc.;Diffuse injury, NVP: Intracranial pathology not visible on CT scan;Diffuse injury with swelling: Cisterns compressed or absent, shift 0-5 mm, no high or mixed density lesion >25 cc Numeric Values

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Duhaime AC, Gean AD, Haacke EM, Hicks R, Wintermark M, Mukherjee P, Brody D, Latour L, Riedy G; Common Data Elements Neuroimaging Working Group Members, Pediatric Working Group Members. Common data elements in radiologic imaging of traumatic brain injury. Arch Phys Med Rehabil. 2010 Nov;91(11):1661-6. [DOI: 10.1016/j.apmr.2010.07.238] Haacke, E.M., Duhaime, A.C., Gean, A.D., Riedy, G., Wintermark, M., Mukherjee, P., Brody, D.L., DeGraba, T., Duncan, T.D., and Elovic, E. (2010). Common data elements in radiologic imaging of traumatic brain injury. Journal of Magnetic Resonance Imaging 32, 516-543, DOI:10.1002/jmri.22259 Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Baseline Risk Assessment Classification Disease/Injury Related Events

Single Pre-Defined Value Selected

C05453 Hypotensive episode indicator HypotnsnEpiInd Indicator of hypotensive episode. In adults, hypotensive episode is defined as systolic blood pressure < 90 mmHg. In children, it is defined as systolic blood pressure < 5th percentile for age Indicator of hypotensive episode. In adults, hypotensive episode is defined as systolic blood pressure < 90 mmHg. In children, it is defined as systolic blood pressure < 5th percentile for age Did participant/subject experience hypotensive episode? Yes;No;Unknown;Suspected Yes;No;Unknown;Suspected Alphanumeric

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McHugh GS, Engel DC, Butcher I, et al. Prognostic value of secondary insults in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):287-93. Silverstone P. Pulse oxymetry of at the road side: a study of pulse oxymetry in immediate care. BMJ. Mar 1989;298(6675):711-13. Stocchetti N, Furlan A, Volta F. Hypoxemia and arterial hypotension at the accident side in head injury. J Trauma. 1996;40:764-67. De Witt DS, Jenkins LW, Prough DS. Enhanced vulnerability to secondary ischemic insults after experimental traumatic brain injury. New Horizon. Aug 1995;3(3):376-383. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Baseline Risk Assessment Classification Disease/Injury Related Events

Single Pre-Defined Value Selected

C05457 Hypoxic episode indicator HypxEpiInd Indicator of hypoxic episode. Hypoxic episode is defined as partial pressure of oxygen in the blood (paO2) < 8kPa (60mmHg) or oxygen saturation (SaO2) < 90% Indicator of hypoxic episode. Hypoxic episode is defined as partial pressure of oxygen in the blood (paO2) < 8kPa (60mmHg) or oxygen saturation (SaO2) < 90% Did participant/subject experience hypoxic episode? Yes;No;Unknown;Suspected Yes;No;Unknown;Suspected Alphanumeric

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McHugh GS, Engel DC, Butcher I, et al. Prognostic value of secondary insults in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):287-93. Silverstone P. Pulse oxymetry of at the road side: a study of pulse oxymetry in immediate care. BMJ. Mar 1989;298(6675):711-13. Stocchetti N, Furlan A, Volta F. Hypoxemia and arterial hypotension at the accident side in head injury. J Trauma. 1996;40:764-67. De Witt DS, Jenkins LW, Prough DS. Enhanced vulnerability to secondary ischemic insults after experimental traumatic brain injury. New Horizon. Aug 1995;3(3):376-383. Steyerberg EW, Mushkudiani N, Perel P, et al. Predicting outcome after traumatic brain injury: development and international validation of prognostic scores based on admission characteristics. PLoS Med. Aug 2008;5(8):e165. MRC CRASH Trial Collaborators. Predicting outcome after traumatic brain injury: practical prognostic models based on large cohort of international patients. BMJ. Feb 2008;336(7641):425-429. Signorini DF, Andrews PJ, Jones PA, et al. Adding insult to injury: the prognostic value of early secondary insults for survival after traumatic brain injury. J Neurol Neurosurg Psychiatry. Jan 1999;66(1):26-31 Pediatric-specific reference(s): Adelson PD, Bratton SL, Carney, NA, Chesnut RM, du Coudray HE, Goldstein B, Kochanek PM, Miller HC, Partington MD, Selden NR, Warden CR, Wright DW. Guidelines for the acute medical management of severe traumatic brain injury in infants, children, and adolescents. Chapter 6. Threshold for treatment of intracranial hypertension. (2003a). Pediatr Crit Care Med 4:S25-S27. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Baseline Risk Assessment Classification Disease/Injury Related Events

Single Pre-Defined Value Selected

CSV