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CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease: Spinal Cord Injury
SubDisease: Spinal Cord Injury
Sub-Domain: General Health History
CRF: Medical History
Item count: 51 (51 distinct CDEs)
CDE ID
CDE Name
Variable Name
Definition / Description
Question Text
Permissible Value
Description
Data Type
Instructions
References
Population
Classification (e.g., Core)
Version #
Version Date
Aliases for Variable Name
CRF Module / Guideline
© or TM
Sub-Domain
Domain
Previous Title
Size
Input Restrictions
Min Value
Max Value
Measurement Type
LOINC ID
SNOMED
caDSR ID
CDISC ID
C00314
Medical history taken date and time
MedclHistTakenDateTime
Date (and time, if applicable and known) the participant/subject's medical history was taken
Date medical (and time) history taken
  
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
3.0
7/25/2013
PT_REL_MED_HIST_DT
Medical History
General Health History
Participant History and Family History
Medical history taken date and time
 
Free-Form Entry
     
2179659
 
C00315
Medical history global assessment indicator
MedclHistGlobalAssmtInd
Indicator of whether the participant/subject has a history of any medical problems/conditions
Does the participant have a history of any medical problems/conditions in the following body systems?
Yes;No;
Yes;No;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
MED_HIST_YN
Medical History
General Health History
Participant History and Family History
Medical history global assessment indicator
 
Single Pre-Defined Value Selected
     
3145578
 
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.
Body System
Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Genitourinary;Hematologic/Lymphatic;Integumentary (skin and/or breast);Musculoskeletal;Neurological;Psychiatric;Respiratory;Other, specify:;
Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Genitourinary;Hematologic/Lymphatic;Integumentary (skin and/or breast);Musculoskeletal;Neurological;Psychiatric;Respiratory;Other, specify:;
Alphanumeric
Record the appropriate body system for each line of medical history.

*For specific questions related to cardiovascular, endocrine, respiratory, musculoskeletal, genitourinary, neurological and gastrointestinal systems, please see the Exploratory list of questions which may be applicable.
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
3.0
7/25/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Body system category
 
Single Pre-Defined Value Selected
     
2002895
 
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
Medical history term
  
Alphanumeric
Enter all significant medical history items, including surgeries, EXCEPT the problem/condition that is the focus of this study. Use only one line per description.

Make sure to record if the following events are in the medical history which are Core items: Any stroke; Ischemic stroke; Hemorrhagic stroke; Hemorrhagic stroke type; 4) Transient ischemic attack (TIA); Carotid stenosis; Epilepsy/ Seizure disorder; Central nervous system infection; Dementia; Head trauma; Head trauma type; Atrial fibrillation (AF)/ flutter; Rheumatic heart disease
SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html)
Adult;Pediatric
Core
3.0
7/25/2013
Refer to SCI CDE Annotated Form
Medical History
General Health History
Participant History and Family History
Medical history condition text
4000
Free-Form Entry
     
2003874
 
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
Start Date
  
Date or Date & Time
Record the date themedical condition/disease started. 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.) and in the format acceptable to the study database
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Medical history condition start date and time
 
Free-Form Entry
     
2543596
 
C00319
Medical history condition ongoing indicator
MedclHistCondOngoingInd
Indicator of whether a medical condition/disease experienced by the participant/subject is ongoing
Ongoing?
Yes;No;
Yes;No;
Alphanumeric
Check Yes or No to indicate if the medical condition/disease is still present
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Medical history condition ongoing indicator
 
Single Pre-Defined Value Selected
     
2736881
 
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
End Date
  
Date or Date & Time
If the condition is not ongoing, record the date (and time) the medical condition/disease stopped. 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.) and in the format acceptable to the study database.
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Medical history condition end date and time
 
Free-Form Entry
     
3145557
 
C19161
Participant safety compromising medical condition indicator
PrtcpntSftyComprmsngMedCondInd
Indicator for serious co-morbid or concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the patient/participant or compromise the participant's ability to participate in the study
Does the participant have any other serious co-morbid or concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the patient/participant or compromise the participant's ability to participate in the study?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one. If this question is answered NO then the rest of the form is blank. If the question is answered YES then the medical history for at least one body system should be recorded
No references available
Adult;Pediatric
Supplemental
1.0
5/29/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C04802
Death date and time
DeathDateTime
Date (and time, if known) of participant's/subject's death
Date of Death (and time)
  
Date or Date & Time
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Death date and time
 
Free-Form Entry
     
2004152
 
C21665
Death cause ICD-10-CM code
DeathCauseICD10CMCode
ICD-10-CM code that describes the cause of participant/subject's death
Primary cause of death
  
Alphanumeric
Record the ICD-10-CM code that corresponds to the primary cause of death
International Classification of Disease, Tenth Revision (ICD-10-CM) - http://www.cdc.gov/nchs/icd/icd10cm.htm
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
 
255
Free-Form Entry
       
C19282
Secondary death cause ICD-10-CM code
SecondDeathCasueICD10Code
ICD-10 code that describes the secondary cause of participant/subject's death
Secondary cause(s) of death
  
Alphanumeric
Record the ICD-10-CM code that corresponds to the secondary cause of death
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
 
4000
Free-Form Entry
       
C19176
Pre spinal cord lesion cardiovascular history condition type
PreSpnlCdLsnCardHistCondTyp
Types of cardiovascular conditions present before spinal cord lesion
Cardiovascular history before spinal cord lesion
None;Cardiac pacemaker;Cardiac surgery, specify;Other cardiac disorders, specify;Hypertension;Hypotension;Orthostatic hypotension;Deep vein thrombosis;Neuropathy (alcoholic, diabetic, and others);Myocardial infarction;Stroke;Family history of cardiovascular disease;Other, specify;Unknown;
None;Cardiac pacemaker;Cardiac surgery, specify;Other cardiac disorders, specify;Hypertension;Hypotension;Orthostatic hypotension;Deep vein thrombosis;Neuropathy (alcoholic, diabetic, and others);Myocardial infarction;Stroke;Family history of cardiovascular disease;Other, specify;Unknown;
Alphanumeric
These codes include conditions present prior to the spinal cord lesion, which may influence the outcomes related to the cardiovascular functions. Altered autonomic control routinely leads to instability of blood pressure following spinal cord lesions. Hypotension is common in acute and chronic spinal cord lesions. In addition, intermittent hypertension can be associated with noxious or non-noxious stimuli and resultant autonomic dysreflexia. Preexisting abnormalities of blood pressure can influence these changes.
Hypertension: (arterial blood pressure >140/90 mmHg).
Hypotension: (systolic arterial blood pressure < 90 mmHg)
Orthostatic hypotension: Symptomatic or asymptomatic decrease in blood pressure usually exceeding 20 mmHg systolic or 10 mmHg diastolic on moving from the supine to an upright position.
Deep vein thrombosis: Thrombosis of the deep veins of the legs, pelvis or arms, due to coagulopathy, stasis, or endothelial injury.
Pre-existing neuropathies (e.g. diabetic or alcoholic neuropathy) and other conditions associated with autonomic dysfunctions (e.g. Parkinson’s disease, multiple sclerosis, traumatic brain injury) can affect altered cardiovascular functions post spinal cord lesion, and should therefore be included.
Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-Sørensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90.
Adult;Pediatric
Exploratory
1.0
5/30/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C19171
Cardiac pacemaker last insertion date
CardiacPacemkrLstInsertionDate
Date at which cardiac pacemaker was last inserted
Cardiac pacemaker, date last inserted
  
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.).
Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-Sørensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90.
Adult;Pediatric
Exploratory
1.0
5/29/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Free-Form Entry
       
C19078
Cardiovascular history cardiac surgery other text
CardioHistCardSurgOTH
The free-text field related to 'Cardiovascular history cardiac surgery type' specifying other text. Type of cardiac surgery or mechanical intervention the participant/subject underwent
Cardiac surgery, specify
  
Alphanumeric
No instructions available
Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-Sørensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90.
Adult;Pediatric
Exploratory
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
 
4000
Free-Form Entry
       
C17473
Cardiovascular history cardiac surgery date
CardioHistCardSurgDate
Date of most recent cardiac surgery or mechanical intervention performed on the participant/subject
Cardiac surgery, date last performed
  
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.).
Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-Sørensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90.
Adult;Pediatric
Exploratory
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Free-Form Entry
       
C19174
Other cardiac disorder type
OthrCardiacDisorderTyp
Type of other cardiac disorder
Other cardiac disorders, specify
  
Alphanumeric
No instructions available
Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-Sørensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90.
Adult;Pediatric
Exploratory
1.0
5/30/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
 
4000
Free-Form Entry
       
C18678
Family history medical condition other text
FamHistMedclCondOTH
The free-text field related to 'Family history medical condition type' specifying other text. Type of medical condition or health related event for which the family history is taken
Family history of cardiac disease
  
Alphanumeric
No instructions available
Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-Sørensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90.
Adult;Pediatric
Exploratory
1.0
5/27/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
 
4000
Free-Form Entry
     
3165585
 
C19348
Cardiovascular history other text
CardVascHistOTH
The free-text field related to "Cardiovascular history condition type" specifying other text.
Other, specify
  
Alphanumeric
No instructions available
Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-Sørensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90.
Adult;Pediatric
Exploratory
1.0
6/12/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
 
255
Free-Form Entry
       
C19177
Pre spinal cord lesion pulmonary conditions present type
PreSpnlCrdLesionPulmnyCondTyp
Types of pulmonary conditions present before spinal cord lesion
Pulmonary conditions present before the spinal cord lesion
None;Asthma;Chronic obstructive pulmonary disease;Sleep apnea;Other, specify;Unknown;
None;Asthma;Chronic obstructive pulmonary disease (including emphysema and chronic bronchitis);Sleep apnea;Other, specify;Unknown;
Alphanumeric
These codes include pulmonary conditions diagnosed prior to the spinal cord lesion that may negatively impact pulmonary function. Asthma and COPD are relatively common conditions associated with airflow obstruction. If the information has been documented once it is not necessary to fill in this variable again, to avoid redundant data.
Biering-Sørensen F, Krassioukov A, Alexander MS, Donovan W, Karlsson AK, Mueller G, Perkash I, William Sheel A, Wecht J, Schilero GJ.International Spinal Cord Injury Pulmonary Function Basic Data Set. Spinal Cord. 2012 Jun; 50(6):418-21.
Adult;Pediatric
Exploratory
1.0
5/30/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Multiple Pre-Defined Values Selected
       
C19178
Pre spinal cord lesion pulmonary condition other text
PreSpnlCrdLsnPulmnyCondOTH
The free-text field related to "Pre spinal cord lesion pulmonary condition type" specifying other text. Type of pulmonary conditions present before spinal cord lesion
Other, specify
  
Alphanumeric
Other, specify
Biering-Sørensen F, Krassioukov A, Alexander MS, Donovan W, Karlsson AK, Mueller G, Perkash I, William Sheel A, Wecht J, Schilero GJ.International Spinal Cord Injury Pulmonary Function Basic Data Set. Spinal Cord. 2012 Jun; 50(6):418-21.
Adult;Pediatric
Exploratory
1.0
5/30/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
 
4000
Free-Form Entry
       
C19179
Pre spinal cord lesion endocrine metabolic condition diagnosed type
PreSpnlCrdLsnMtblicCondTyp
Type of endocrine & metabolic condition diagnosed before spinal cord lesion
Endocrine & Metabolic conditions diagnosed before the spinal cord lesion
None;Diabetes mellitus;Lipid disorder;Osteoporosis;Thyroid disease;Other, specify;Unknown;
None;Diabetes mellitus;Lipid disorder;Osteoporosis;Thyroid disease;Other, specify;Unknown;
Alphanumeric
These codes include endocrine and metabolic conditions diagnosed prior to the spinal cord lesion that may negatively impact health and function after spinal cord lesion.
Bauman WA, Biering-Sørensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72.
Adult;Pediatric
Exploratory
1.0
6/2/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C06358
Diabetes mellitus type
DiabetesMellitusTyp
Type of diabetes mellitus
Diabetes mellitus
  
Alphanumeric
Choose one
At time of spinal cord lesion, a patient may present with a history of type 1 or type 2 diabetes mellitus (The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus, 2003), which may be more difficult to manage after acute spinal cord injury (SCI) due to glucocorticoid administration, heightened stress, variable caloric intake, and severe immobilization; chronic injury may be associated with a further increase in insulin resistance in association with a reduction in muscle mass (i.e., the primary insulin responsive tissue responsible for glucose deposition). The designation of type 1 or type 2 diabetes mellitus is usually determined on clinical judgement. Juvenile-onset patients should be classified as type 1, and all others, as type 2. Appreciated: the patient with type 2 diabetes may have features distinctive of a patient with type 1 diabetes, including a tendency for ketosis, but such patients are classified clinically as insulin-requiring type 2 diabetes. Therefore, the clinician must decide if a patient has type 1 or a type 2 diabetes mellitus.
Bauman WA, Biering-Sørensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72. The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus, Follow-up Report on the Diagnosis of Diabetes Mellitus. Diabetes Care 2003; 26:3160-3167.
Adult;Pediatric
Exploratory
3.0
7/24/2013
DIABTYHX
Medical History
General Health History
Participant History and Family History
Diabetes mellitus type
 
Single Pre-Defined Value Selected
       
C18168
Total cholesterol value
TotCholstrlVal
Total cholesterol level measured
Total cholesterol (TC)
  
Numeric Values
Dyslipidemias may be worsened by a reduction in the serum HDL cholesterol value in those with acute or chronic SCI. Therefore, to have the ability to determine the effect of SCI per se on the lipid profile, this information, if available, should be provided (if several lipid profiles are available, the most recent values prior to SCI should be provided), along with the date obtained. The units of measurement to be used in this data set are mg/dL.
Bauman WA, Biering-Sørensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72.
Adult
Exploratory
3.0
7/17/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Free-Form Entry
  
milligrams per deciliter
    
C18169
Triglycerides value
TriglcrdVal
Triglycerides measured
Triglycerides (TG)
  
Numeric Values
Dyslipidemias may be worsened by a reduction in the serum HDL cholesterol value in those with acute or chronic SCI. Therefore, to have the ability to determine the effect of SCI per se on the lipid profile, this information, if available, should be provided (if several lipid profiles are available, the most recent values prior to SCI should be provided), along with the date obtained. The units of measurement to be used in this data set are mg/dL.
Bauman WA, Biering-Sørensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72.
Adult
Exploratory
3.0
7/17/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Free-Form Entry
  
milligrams per deciliter
    
C18146
HDL cholesterol value
HDLCholstrlVal
HDL cholesterol measured
HDL cholesterol
  
Numeric Values
Dyslipidemias may be worsened by a reduction in the serum HDL cholesterol value in those with acute or chronic SCI. Therefore, to have the ability to determine the effect of SCI per se on the lipid profile, this information, if available, should be provided (if several lipid profiles are available, the most recent values prior to SCI should be provided), along with the date obtained. The units of measurement to be used in this data set are mg/dL.
Bauman WA, Biering-Sørensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72.
Adult
Exploratory
3.0
7/17/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Free-Form Entry
0
500
milligram per deciliter
    
12-19-2018
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