CDE Detailed Report

Disease: Traumatic Brain Injury
Sub-Domain: General Health History
CRF: Significant Medical History

Displaying 1 - 15 of 15
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 / 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
C00316 Medical history condition end date and time MedclHistCondEndDateTime Date (and time, if applicable and known) for the end of an event in the participant's/subject's medical history Date (and time, if applicable and known) for the end of an event in the participant's/subject's medical history Medical history condition end date and time 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 2013-07-25 08:54:08.2 Significant Medical History General Health History Participant History and Family History

Free-Form Entry

3145557
C18666 Body system other text BodySysOTH The free-text field related to 'Body system category' specifying other text. Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured The free-text field related to 'Body system category' specifying other text. Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured Other, specify Alphanumeric

Choose one. Response is obtained by report of the participant/subject or proxy as soon as possible after visit/admission. Document the date the history was obtained so it can be determined whether this information was obtained prior to study enrollment or later. Recommend collection at least on date of TBI or at time of first medical treatment. Comorbidity prior to injury may influence the disease course and chances of recovery. Serious comorbidity or comorbidity that may influence the assessment of outcome are generally considered exclusion criteria in randomized clinical trials. It is therefore highly relevant to accurately record the significant relevant medical history.

Review of Symptoms from Centers for Medicare and Medicaid Services https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Significant Medical History General Health History Participant History and Family History 4000

Free-Form Entry

2002895
C00317 Medical history condition start date and time MedclHistCondStrtDateTime Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history Medical history condition start date and time 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 2013-07-25 08:54:08.2 Significant Medical History General Health History Participant History and Family History

Free-Form Entry

2543596
C18745 Perinatal neurologic event other text PerinatlNeurolEventOTH The free-text field related to 'Perinatal neurologic event type' specifying other text. Type of perinatal neurologic injury The free-text field related to 'Perinatal neurologic event type' specifying other text. Type of perinatal neurologic injury Other, specify Alphanumeric

Choose all that apply. Response is obtained from report by participant/subject or proxy. Document whether this information was obtained prior to study enrollment or later. Recommend collection as soon as possible after visit/admission. This element is recommended for pediatric studies.TBI as a result of the birth process is a common and well-described phenomenon. A recent study of 97 asymptomatic neonates found that 26% of those born vaginally had TBI identified on a 3T MRI performed an average of 21 days after birth. Unlike TBI due to other causes, the locations of the ICH associated with birth are almost exclusively posterior fossa/occipital lobes. Presenting symptoms due to birth-related TBI can range from none to severe and include apnea, bradycardia and/or seizures.

Holden K, Titus M, Van_Tassel P (1999) Cranial magnetic resonance imaging examination of normal term neonates: a pilot study. J Child Neurol 145/9/2011708-710. Pollina J, Dias M, Li V, Kachurek D, Arbesman M (2001) Cranial birth injuries in term newborn infants. Pediatr Neurosurg 35:113-119. Looney C, Smith J, Merck L, Wolfe H, Chescheir N, Hamer R, Gilmore J (2007) Intracranial hemorrhage in asymptomatic neonates: prevalence on MR images and relationship to obstetric and neonatal risk factors. Radiology 242:535-541. Whitby E, Griffiths P, Rutter S, Smith M, Sprigg A, Ohadike P, Davies N, Rigby A, Paley M (Lancet) Frequency and natural history of subdural haemorrhages in babies and relation to obstetric factors. 2004 363:846-851. Towner D, Castro M, Eby-Wilkens E, Gilbert W (1999) Effect of mode of delivery in nulliparous women on neonatal intracranial injury. N Engl J Med 341:1709-1714. Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Significant Medical History General Health History Participant History and Family History 4000

Free-Form Entry

C00319 Medical history condition ongoing indicator MedclHistCondOngoingInd Indicator of whether a medical condition/disease experienced by the participant/subject is ongoing Indicator of whether a medical condition/disease experienced by the participant/subject is ongoing Medical history condition ongoing indicator Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one.

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Significant Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

2736881
C00321 Medical history for body system indicator MedclHistBodySysInd Indicator of whether the participant/subject has a history of medical problems/conditions for the specific body system Indicator of whether the participant/subject has a history of medical problems/conditions for the specific body syste Does the participant/subject have a history of any medical problems/conditions in the following body systems? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. Response is obtained by report of the participant/subject or proxy as soon as possible after visit/admission. Document the date the history was obtained so it can be determined whether this information was obtained prior to study enrollment or later. Recommend collection at least on date of TBI or at time of first medical treatment. Comorbidity prior to injury may influence the disease course and chances of recovery. Serious comorbidity or comorbidity that may influence the assessment of outcome are generally considered exclusion criteria in randomized clinical trials. It is therefore highly relevant to accurately record the significant relevant medical history.

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 16:57:17.79 Significant Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C00322 Medical history condition text MedclHistCondTxt Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history Alphanumeric

Recommend collection at least during initial medical treatment. This element is recommended for pediatric studies.

SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html) Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Significant Medical History General Health History Participant History and Family History 4000

Free-Form Entry

2003874
C00323 Head injury prior number HeadInjPriorNum Number of prior head injuries, if previous TBI history Number of prior head injuries, if previous TBI history Head injury prior number Numeric Values

Response is obtained from report by participant/subject or proxy. Document whether this information was obtained prior to study enrollment or later. Recommend collection as soon as possible after visit/admission.

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Significant Medical History General Health History Participant History and Family History

Free-Form Entry

0 99
C00324 Concussion prior number ConcussionPriorNum Number of prior concussions Number of prior concussions Number of concussions prior to the current injury Numeric Values

Response is obtained from report by participant/subject or proxy. Document whether this information was obtained prior to study enrollment or later. Recommend collection as soon as possible after visit/admission.

Michael McCrea, PhD, Thomas Hammeke, PhD, Gary Olsen, MS, Peter Leo, BS, and Kevin Guskiewicz, ATC, PhD. Unreported Concussion in High School Football Players. Clin J Sport Med Volume 14, Number 1, January 2004 Adult;Pediatric Basic 3.00 2013-07-20 10:21:25.65 Significant Medical History General Health History Participant History and Family History

Free-Form Entry

0 99
C00325 Blast prior exposure number BlastPriorExposurNum Number of blasts the participant has been exposed to prior to his or her current injury Number of blasts the participant has been exposed to prior to his or her current injur Blast prior exposure number Numeric Values

This element should be collected in studies including military populations.

Holden K, Titus M, Van_Tassel P (1999) Cranial magnetic resonance imaging examination of normal term neonates: a pilot study. J Child Neurol 145/9/2011708-710. Pollina J, Dias M, Li V, Kachurek D, Arbesman M (2001) Cranial birth injuries in term newborn infants. Pediatr Neurosurg 35:113-119. Looney C, Smith J, Merck L, Wolfe H, Chescheir N, Hamer R, Gilmore J (2007) Intracranial hemorrhage in asymptomatic neonates: prevalence on MR images and relationship to obstetric and neonatal risk factors. Radiology 242:535-541. Whitby E, Griffiths P, Rutter S, Smith M, Sprigg A, Ohadike P, Davies N, Rigby A, Paley M (Lancet) Frequency and natural history of subdural haemorrhages in babies and relation to obstetric factors. 2004 363:846-851. Towner D, Castro M, Eby-Wilkens E, Gilbert W (1999) Effect of mode of delivery in nulliparous women on neonatal intracranial injury. N Engl J Med 341:1709-1714. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Significant Medical History General Health History Participant History and Family History

Free-Form Entry

C00326 Perinatal neurologic event type PerinatlNeurolEventTyp Type of perinatal neurologic injury Type of perinatal neurologic injury Perinatal neurologic event type Subarachnoid hemorrhage;Intraparenchymal hemorrhage;Intraventricular hemorrhage;Hypoxia;Other, specify;None;Subdural hemorrhage Subarachnoid hemorrhage;Intraparenchymal hemorrhage;Intraventricular hemorrhage;Hypoxia;Other, specify;None;Subdural hemorrhage Alphanumeric

Choose all that apply. Response is obtained from report by participant/subject or proxy. Document whether this information was obtained prior to study enrollment or later. Recommend collection as soon as possible after visit/admission. This element is recommended for pediatric studies.TBI as a result of the birth process is a common and well-described phenomenon. A recent study of 97 asymptomatic neonates found that 26% of those born vaginally had TBI identified on a 3T MRI performed an average of 21 days after birth. Unlike TBI due to other causes, the locations of the ICH associated with birth are almost exclusively posterior fossa/occipital lobes. Presenting symptoms due to birth-related TBI can range from none to severe and include apnea, bradycardia and/or seizures.

Holden K, Titus M, Van_Tassel P (1999) Cranial magnetic resonance imaging examination of normal term neonates: a pilot study. J Child Neurol 145/9/2011708-710. Pollina J, Dias M, Li V, Kachurek D, Arbesman M (2001) Cranial birth injuries in term newborn infants. Pediatr Neurosurg 35:113-119. Looney C, Smith J, Merck L, Wolfe H, Chescheir N, Hamer R, Gilmore J (2007) Intracranial hemorrhage in asymptomatic neonates: prevalence on MR images and relationship to obstetric and neonatal risk factors. Radiology 242:535-541. Whitby E, Griffiths P, Rutter S, Smith M, Sprigg A, Ohadike P, Davies N, Rigby A, Paley M (Lancet) Frequency and natural history of subdural haemorrhages in babies and relation to obstetric factors. 2004 363:846-851. Towner D, Castro M, Eby-Wilkens E, Gilbert W (1999) Effect of mode of delivery in nulliparous women on neonatal intracranial injury. N Engl J Med 341:1709-1714. Pediatric Supplemental 3.00 2013-07-19 21:21:51.533 Significant Medical History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C00312 Body system category BodySysCat Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body system Body system category Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify: Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify: Alphanumeric

Choose one. Response is obtained by report of the participant/subject or proxy as soon as possible after visit/admission. Document the date the history was obtained so it can be determined whether this information was obtained prior to study enrollment or later. Recommend collection at least on date of TBI or at time of first medical treatment. Comorbidity prior to injury may influence the disease course and chances of recovery. Serious comorbidity or comorbidity that may influence the assessment of outcome are generally considered exclusion criteria in randomized clinical trials. It is therefore highly relevant to accurately record the significant relevant medical history.

Review of Symptoms from Centers for Medicare and Medicaid Services https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Significant Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

2002895
C00327 Prior traumatic injury indicator PriorTraumInjryInd Indicator of prior traumatic injury found either historically, previous emergency department visits, radiographic findings, or signs or symptoms at time of presentation Indicator of prior traumatic injury found either historically, previous emergency department visits, radiographic findings, or signs or symptoms at time of presentatio Prior traumatic injury indicator Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. Document whether this information was obtained prior to study enrollment or later. Recommend collection as soon as possible after visit/admission from subject or proxy. This element is recommended for pediatric studies.

No references available Adult;Pediatric Supplemental 3.00 2013-07-19 21:21:51.533 Significant Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C00313 Medical history condition SNOMED CT code MedclHistCondSNOMEDCTCode Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject Medical history condition for SNOWMED CT code Alphanumeric

Recommend collection at least during initial medical treatment. This element is recommended for pediatric studies.

SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html) Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Significant Medical History General Health History Participant History and Family History 255

Free-Form Entry

C00328 Prior traumatic injury type PriorTraumInjryType General location of traumatic injury, if evidence of prior traumatic injury General location of traumatic injury, if evidence of prior traumatic injury Prior traumatic injury type Brain Injury;Spine Injury;Other Extracranial Injury Brain Injury;Spine Injury;Other Extracranial Injury Alphanumeric

Choose all that apply. This element is recommended for pediatric studies.

No references available Adult;Pediatric Supplemental 3.00 2013-07-19 21:21:51.533 Significant Medical History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

CSV