CDE Detailed Report
Subdomain Name: 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 / 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
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| 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 medical history | Date (and time, if applicable and known) for the end of an event in the participant'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 | 3.10 | 2024-02-29 15:42:44.0 | Significant Medical History | General Health History | Participant History and Family History |
Free-Form Entry |
3145557 | |||||||||
| C18666 | Body system category other text | BodySysCatOTH | 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 | 1.10 | 2023-11-07 08:40:35.0 | 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 medical history | Date (and time, if applicable and known) for the start of an event in the participant'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 | 3.10 | 2024-02-29 15:42:43.0 | 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 |
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| C00319 | Medical history condition ongoing indicator | MedclHistCondOngoingInd | Indicator of whether a medical condition/disease experienced by the participant is ongoing | Indicator of whether a medical condition/disease experienced by the participant is ongoing | Medical history condition ongoing indicator | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Choose one. |
No references available | Adult;Pediatric | Supplemental | 4.00 | 2024-02-29 15:42:44.0 | 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
