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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: Physical Examinations
CRF: Clinical Assessment
Item count: 126 (126 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
C06005
Data collected date and time
DataCollDateTime
Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed.
Assessment Date/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.).
Injury through the spinal column is defined as any break, rupture, ligament tear, disruption, or crack through the bony vertebral elements or through the non-bony disc and ligamentous soft tissues between the vertebrae from the occipital condyles to the sacrum. Patients with cervical spondylosis and spinal stenosis may suffer a traumatic spinal cord injury without a spinal column injury.
Dvorak MF, Wing PC, Fehlings MG, Vaccaro AR, Itshayek E, Biering-Sorensen F, Noonan VK. International spinal cord injury spinal column injury basic data set. Spinal Cord. 2012 Nov;50(11):817-21.
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Clinical Assessment
Physical Examinations
Assessments and Examinations
Data collected date and time
 
Free-Form Entry
       
C06427
Spinal column injury indicator
SpnlColmInjInd
Indicator of whether there was any disruption through the spinal column including the bony vertebral elements and their supporting ligaments, capsules, discs, and other supporting soft tissues.
Spinal column injury (-ies)
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Being able to distinguish between single versus multiple levels of spinal column injury is often challenging. Critical to this distinction is the fact that a single injury may occur; i) at one vertebral level (e.g. C6 Burst Fracture); ii) at a single motion segment (e.g. a C5-6 bilateral facet dislocation) where a motion segment is defined as two adjacent vertebrae and their interconnecting discs and
ligamentous structures; or iii) over two or more adjacent and contiguousmotion segments (e.g. a “teardrop” fracture of C6 where the injury spans C5-C7). Alternately, a multiple level injury consists of two or more single column injuries separated by at least one completely intact vertebra or motion segment(e.g. a C5-6 facet dislocation and a C2 hangman’s fracture).
Dvorak MF, Wing PC, Fehlings MG, Vaccaro AR, Itshayek E, Biering-Sorensen F, Noonan VK. International Spinal Cord Injury Spinal Column Injury Basic Data Set. Spinal Cord. 2012 Nov;50(11):817-821; doi: 10.1038/sc.2012.60.
Adult;Pediatric
Supplemental
3.0
7/17/2013
SPNCLINJ
Clinical Assessment
Physical Examinations
Assessments and Examinations
Spinal column injury indicator
 
Single Pre-Defined Value Selected
       
C06428
Spinal column injury extent type
SpnlColmInjExntTyp
In the presence of an injury through the spine, this element documents whether there is a single level spinal column injury or if there are multiple levels involved.
Single or multiple spinal column level injury (-ies)
Single;Multiple;Unknown;
Single;Multiple;Unknown;
Alphanumeric
Choose one
Dvorak MF, Wing PC, Fehlings MG, Vaccaro AR, Itshayek E, Biering-Sorensen F, Noonan VK. International Spinal Cord Injury Spinal Column Injury Basic Data Set. Spinal Cord. 2012 Nov;50(11):817-821; doi: 10.1038/sc.2012.60.
Adult;Pediatric
Supplemental
3.0
7/17/2013
NOINJLVL
Clinical Assessment
Physical Examinations
Assessments and Examinations
Spinal column injury extent type
 
Single Pre-Defined Value Selected
       
C06429
Spinal column injury number
SpnlColmInjNum
Number assigned to the spinal column injury. The spinal column injuries are assigned numbers starting with the most cephalic spinal column injury.
Spinal column injury number
  
Numeric Values
1 – Most cephalic spinal column injury involving one or more adjacent vertebral levels and/or one or more adjacent and contiguous motion segments.
2 – If there are two or more discrete spinal column injuries, this is the second most cephalic spinal column injury involving one or more adjacent vertebral levels and/or one or more adjacent and
contiguous motion segments separated by at least one intact vertebral level to the above or below spinal column injury.
3, 4, etc. If there are three or more discrete spinal column injuries, this is the third, fourth, etc. most cephalic spinal column injury involving one or more adjacent vertebral levels and/or one or more
adjacent and contiguous motion segments separated by at least one intact vertebral level to the above or below spinal column injury.
99 - Unknown
Dvorak MF, Wing PC, Fehlings MG, Vaccaro AR, Itshayek E, Biering-Sorensen F, Noonan VK. International Spinal Cord Injury Spinal Column Injury Basic Data Set. Spinal Cord. 2012 Nov;50(11):817-821; doi: 10.1038/sc.2012.60.
Adult;Pediatric
Supplemental
3.0
7/17/2013
SPNINJNO
Clinical Assessment
Physical Examinations
Assessments and Examinations
Spinal column injury order of nearness to head number
 
Free-Form Entry
       
C05452
Spinal injury anatomic site
SpnlInjAntmicSit
Anatomic site(s) of the spine injury represented as level(s) of the spinal-injured vertebrae.
Spinal column injury level
C0;C1;C2;C3;C4;C5;C6;C7;T1;T2;T3;T4;T5;T6;T7;T8;T9;T10;T11;T12;L1;L2;L3;L4;L5;S1;S2;S3;S4-5;
C0;C1;C2;C3;C4;C5;C6;C7;T1;T2;T3;T4;T5;T6;T7;T8;T9;T10;T11;T12;L1;L2;L3;L4;L5;S1;S2;S3;S4-5;
Alphanumeric
The element may be included if relevant to the study. For additional details like permissible values, see the data dictionary associated with this CRF.
The element may be included if relevant to the study. For additional details like permissible values, see the data dictionary associated with this CRF.
vC00 represents C0 and is the occiput.
The code vX99 should be used only if the level is completely unknown.
In the case of multiple spinal injuries, a separate entry will be completed for each spinal column injury level.
Dvorak MF, Wing PC, Fehlings MG, Vaccaro AR, Itshayek E, Biering-Sorensen F, Noonan VK. International Spinal Cord Injury Spinal Column Injury Basic Data Set. Spinal Cord. 2012 Nov;50(11):817-821; doi: 10.1038/sc.2012.60.
Adult;Pediatric
Supplemental
3.0
7/20/2013
SCI CDEs: SPNINLVL
Clinical Assessment
Physical Examinations
Assessments and Examinations
Spine injury anatomic site
 
Multiple Pre-Defined Values Selected
       
C06430
Disc posterior ligamentous complex injury indicator
DiscPostrLigmntComplxInjInd
For each of the level(s) of the spinal-injured vertebra(e) whether there was evidence of either a disc or a posterior ligamentous complex injury (occiput to sacrum). Posterior ligamentous complex injury is defined as the presence of acute disruption or injury to the posterior ligamentous complex through the spinal column from the occiput to the level of the sacrum. Disc Injury is defined as a traumatic disruption of the annulus of the disc through either distraction, translation, or rotation. It will also include a traumatic disc protrusion causing a spinal cord injury. Isolated traumatic disc injuries commonly occur with hyper-extension mechanisms in the cervical spine.
Disc/posterior ligamentous complex injury
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one - This is to be filled in for each level of injury, starting with the most cephalic injury. Acute injury to the posterior ligamentous complex should be diagnosed clinically or radiographically. Clinical evidence relies on the presence of marked local bruising and/or a palpable interspinous gap possibly with local tenderness. Radiologic diagnosis is dependent on the existence of a widened interspinous space on AP or lateral x-ray or reformatted CT of the spine, or by appropriate MRI. It may also appear as avulsion of a bone from the spinous processes or lamina. When a traumatic injury to the disc and annulus occurs in association with posterior element distraction, subluxation, or dislocation, this will be recorded as a disc and posterior ligamentous complex injury. In the case of multiple spinal column injuries, a separate entry will be filled out for each level of spinal column injury.
Posterior ligamentous complex injury will be defined as the presence of acute disruption or injury to the posterior ligamentous complex through the spinal column from the occiput to the level of the sacrum. Acute injury to the posterior ligamentous complex will
be diagnosed clinically or radiographically. Clinical evidence relies on the presence of marked local bruising and/or a palpable interspinous gap possibly with local tenderness. Radiologic diagnosis is dependent on the existence of a widened interspinous
space on AP or lateral x-ray or reformatted CT of the spine, or by appropriate MRI. It may also appear as avulsion of a bone from the spinous processes or lamina. Disc Injury will be defined as a traumatic disruption of the annulus of the disc through either distraction, translation, or rotation. It will also include a traumatic disc protrusion causing a spinal cord injury. Isolated traumatic disc injuries commonly occur with hyperextension mechanisms in the cervical spine. When a traumatic injury to the disc and annulus occurs in association with posterior element distraction, subluxation, or dislocation, this will be recorded as a disc and posterior ligamentous complex injury. In the case of multiple spinal column injuries, a separate entry will be filled out for each level of spinal column injury.
Boyd,M., Dvorak,M.F., & Fisher,C. Injury of the posterior ligamentous complex of the thoracolumbar spine: a prospective evaluation of the diagnostic accuracy of magnetic resonance imaging. Spine. 34, E841-E847 (2009).
Dvorak,M.F., Fisher,C.G., Fehlings,M.G., Rampersaud,Y.R., Oner,F.C., & Aarabi B., Vaccaro,A.R. The surgical approach to subaxial cervical spine injuries: an evidence-based algorithm based on the SLIC classification system. Spine. 32, 2620-2629 (2007). Lee,J.Y., Vaccaro,A.R., Schweitzer,K.M. Jr., Lim,M.R., Baron,E.M., Rampersaud,R., Oner,F.C., Hulbert,R.J., Hedlund,R., Fehlings,M.G., Arnold,P., Harrop,J., Bono,C.M., Anderson,P.A., Patel,A., Anderson,D.G., & Harris,M.B. Assessment of injury to the thoracolumbar posterior ligamentous complex in the setting of normal-appearing plain radiography. Spine J. 7, 422-427 (2007). Patel,A.A. Dailey,A., Brodke,D.S., Daubs,M., Anderson,P.A., Hurlbert,R.J., & Vacccaro,A.R. Subaxial cervical spine trauma classification: the Subaxial Injury Classification system and case examples. Neurosurg. Focus. 25, E8 (2008). Rihn,J.A., Fisher,C., Harrop,J., Morrison,W., Yang,N., & Vaccaro,A.R. Assessment of the posterior ligamentous complex following acute cervical spine trauma. J. Bone Joint Surg. Am. 92, 583-589 (2010). Vaccaro,A.R., Rihn,J.A., Saravanja,D., Anderson,D.G., Hilibrand,A.S., Albert,T.J., Fehlings,M.G., Morrison,W., Flanders,A.E., France,J.C., Arnold,P., Anderson,P.A., Friel,B., Malfair,D., Street,J., Kwon,B., Paquette,S., Boyd,M., Dvorak,M.F., & Fisher,C. Injury of the posterior ligamentous complex of the thoracolumbar spine: a prospective evaluation of the diagnostic accuracy of magnetic resonance imaging. Spine. 34, E841-E847 (2009). Vaccaro,A.R., Lee,J.Y., Schweitzer,K.M. Jr., Lim,M.R., Baron,E.M., Oner,F.C., Hulbert,R.J., Hedlund,R., Fehlings,M.G., Arnold,P., Harrop,J., Bono,C.M., Anderson,P.A., Anderson,D.G., & Harris,M.B. Assessment of injury to the posterior ligamentous complex in thoracolumbar spine trauma. Spine J. 6, 524-528 (2006).
Dvorak MF, Wing PC, Fehlings MG, Vaccaro AR, Itshayek E, Biering-Sorensen F, Noonan VK. International Spinal Cord Injury Spinal Column Injury Basic Data Set. Spinal Cord. 2012 Nov;50(11):817-821; doi: 10.1038/sc.2012.60.
Adult;Pediatric
Supplemental
3.0
7/17/2013
DISCINJ
Clinical Assessment
Physical Examinations
Assessments and Examinations
Spine disc or posterior ligamentous complex injury indicator
 
Single Pre-Defined Value Selected
       
C06431
Spinal injury traumatic translation indicator
SpnlInjTraumtcTransltnInd
For each of the spinal column injury level(s) whether there was any traumatic translation (occiput to sacrum). Translation is defined as sagittal and/or coronal plane mal-alignment of adjacent vertebra as seen on lateral and/or AP radiographs respectively; it consists of movement of 3.5 mm or more of one cervical vertebra on top of the adjacent vertebra or movement of 2.5 mm or more of one thoracic and lumbar vertebra on top of the adjacent vertebra1 (on available imaging).
Traumatic translation
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one - This is to be filled in for each level of injury, starting with the most cephalic injury. Malalignment that was caused by a degenerative process such as degenerative spondylolisthesis is not considered traumatic translation, and the value "No" should be recorded. In the case of multiple spinal injuries, a separate entry will be filled out regarding each level.
Translation will be defined as sagittal and/or coronal plane malalignment of adjacent vertebra as seen on lateral and/or AP radiographs respectively; it consists of movement of 3.5 mm or more of one cervical vertebra on top of the adjacent vertebra or movement of 2.5 mm or more of one thoracic and lumbar vertebra on top of the adjacent vertebra (on available imaging). Malalignment that was caused by a degenerative process such as degenerative spondylolisthesis is not considered traumatic translation, and the value "0" (No) should be recorded. In the case of multiple spinal injuries, a separate entry will be filled out regarding each level.
Dvorak MF, Wing PC, Fehlings MG, Vaccaro AR, Itshayek E, Biering-Sorensen F, Noonan VK. International Spinal Cord Injury Spinal Column Injury Basic Data Set. Spinal Cord. 2012 Nov;50(11):817-821; doi: 10.1038/sc.2012.60.
Adult;Pediatric
Supplemental
3.0
7/17/2013
TRTRANSL
Clinical Assessment
Physical Examinations
Assessments and Examinations
Spine injury traumatic translation indicator
 
Single Pre-Defined Value Selected
       
C06112
Ventilatory assistance type
VentiltryAsstTyp
Type of assistance device utilized to augment ventilation
Current Utilization of Ventilatory Assistance
Bi-level Positive Airway Pressure;Diaphragmatic pacing device;Mechanical ventilation;None;Other,specify;Phrenic Nerve Stimulation;Unknown;
Bi-level Positive Airway Pressure (BiPAP);Diaphragmatic pacing device;Mechanical ventilation;None;Other, specify;Phrenic Nerve Stimulation;Unknown;
Alphanumeric
Record any assistance device utilized at the time of evaluation to augment ventilation. For each device indicate if it was utilized at the time of evaluation.
Respiratory insufficiency is common following spinal cord lesions. Ventilatory assistance devices include, but are not limited to: mechanical ventilators, phrenic nerve stimulators, diaphragmatic pacers, external
negative pressure devices, and bi-level positive airway pressure (BiPAP). These devices do not include routine administration of oxygen, intermittent positive pressure breathing (IPPB), or continuous positive airway pressure (CPAP). Wording of this variable reflects the International Spinal Cord Injury Core Data Set for the type of ventilatory assistance used to sustain respiration at discharge after the initial rehabilitation period following the spinal lesion (DeVivo et al. 2006). As the situation may have changed since discharge from the initial inpatient period the question is asked.
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
Supplemental
3.0
7/17/2013
Refer to SCI CDE Annotated Form
Clinical Assessment
Physical Examinations
Assessments and Examinations
Ventilatory assistance type
 
Multiple Pre-Defined Values Selected
       
C06114
Mechanical ventilation utilization frequency
MechnclVentUtlztnFreq
Specifies frequency that the participant/ subject uses mechanical ventilation
Mechanical ventilation
Less than 24 hours per day;24 hours per day;Unknown number of hours per day;
Less than 24 hours per day;24 hours per day;Unknown number of hours per day;
Alphanumeric
Respiratory insufficiency is common following spinal cord lesions. Ventilatory assistance devices include, but are not limited to: mechanical ventilators, phrenic nerve stimulators, diaphragmatic pacers, external negative pressure devices, and bi-level positive airway pressure (BiPAP). These devices do not include routine administration of oxygen, intermittent positive pressure breathing (IPPB), or continuous positive airway pressure (CPAP). Wording of this variable reflects the International Spinal Cord Injury Core Data Set for the type of ventilatory assistance used to sustain respiration at discharge after the initial rehabilitation period following the spinal lesion (DeVivo et al. 2006). As the situation may have changed since discharge from the initial inpatient period the question is asked.
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
Supplemental
3.0
7/17/2013
MCVNTFRQ
Clinical Assessment
Physical Examinations
Assessments and Examinations
Mechanical ventilation utilization frequency
 
Single Pre-Defined Value Selected
       
C18784
Ventilatory assistance other text
VentiltryAsstOTH
The free-text field related to 'Ventilatory assistance type' specifying other text. Type of assistance device utilized to augment ventilation
Other, specify
  
Alphanumeric
Record any assistance device utilized at the time of evaluation to augment ventilation. For each device indicate if it was utilized at the time of evaluation.
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
Supplemental
3.0
7/17/2013
Aliases for variable name not defined
Clinical Assessment
Physical Examinations
Assessments and Examinations
 
4000
Free-Form Entry
       
C19785
Medical history pulmonary bilevel positive airway pressure start date
MedHistLabPrPlBiPAPStrtDt
Date of start of bilevel positive airway pressure
Bi-level Positive Airway Pressure (BiPAP) Date started use
  
Date or Date & Time
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
2/5/2015
Aliases for variable name not defined
Clinical Assessment
Physical Examinations
Assessments and Examinations
  
Free-Form Entry
       
C06109
Pulmonary condition after spinal cord lesion last year type
PulmnCndAftrSpnlCrdLsnLstYrTyp
Type of pulmonary complication or condition that may have occurred after the spinal cord lesion (within the last year)
Pulmonary complications and conditions after the spinal cord lesion within last year
Pneumonia;Chronic obstructive pulmonary disease;Sleep apnea;Other, specify;Unknown;None;
Pneumonia;Chronic obstructive pulmonary disease (including emphysema and chronic bronchitis);Sleep apnea;Other, specify;Unknown;None;
Alphanumeric
For each pulmonary complication or condition indicate if occurred within the last year.
Pneumonia is one of the leading causes of mortality in individuals with spinal cord lesions (Hartkopp et al. 1997; DeVivo et al. 1999; Lidal et al. 2007), therefore it is important to record this information in detail and whenever possible. Other respiratory complications and conditions may develop after sustaining a spinal cord lesion, including atelectasis (lung collapse), and other disorders with high disease prevalence in the general population (i.e. asthma, COPD). Sleep apnea, either obstructive or central in etiology, is a common yet frequently unrecognized condition among individuals with spinal cord lesions (Leduc et al. 2007; Berlowitz et al. 2005). Sleep apnea may adversely affect sleep quality and daytime functioning, and studies in the general population suggest that obstructive sleep apnea is a risk factor for hypertension, stroke, and myocardial infarction.
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
Supplemental
3.0
7/17/2013
Refer to SCI CDE Annotated Form
Clinical Assessment
Physical Examinations
Assessments and Examinations
Pulmonary complication or condition after spinal cord lesion within last year type
 
Multiple Pre-Defined Values Selected
       
C18783
Pulmonary condition after spinal cord lesion last year other text
PulmnCndAftrSpnlCrdLsnLstYrOTH
The free-text field related to 'Pulmonary condition after spinal cord lesion last year type' specifying other text. Type of pulmonary complication or condition that may have occurred after the spinal cord lesion (within the last year)
Other, specify
  
Alphanumeric
For each pulmonary complication or condition indicate if occurred within the last year.
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
Supplemental
3.0
7/17/2013
Aliases for variable name not defined
Clinical Assessment
Physical Examinations
Assessments and Examinations
 
4000
Free-Form Entry
       
C06110
Pneumonia episode treat antibiotic past year number
PnmnaEpsdTrtAntibtcPstYrNum
Number of pneumonia episodes treated with antibiotics occurring after the spinal cord lesion and within the last year
Number of episodes treated with antibiotics
  
Numeric Values
Only answer if there is a history of pneumonia after spinal cord lesion and within the last year. If number of episodes is unknown then code 999 (999 = Unknown).
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
Supplemental
3.0
7/17/2013
NOEPANTB
Clinical Assessment
Physical Examinations
Assessments and Examinations
Pneumonia episodes treated with antibiotics past year number
 
Free-Form Entry
       
C06111
Pneumonia episode require hospitalization past year number
PnmnaEpsdReqHsptlztnPstYrNum
Number of pneumonia episodes requiring hospitalization occurring after the spinal cord lesion and within the last year
Number of episodes requiring hospitalization
  
Numeric Values
Only answer if there is a history of pneumonia after spinal cord lesion and within the last year. If number of episodes is unknown then code 999 (999 = Unknown).
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
Supplemental
3.0
7/17/2013
NOEPHOSP
Clinical Assessment
Physical Examinations
Assessments and Examinations
Pneumonia episodes requiring hospitalization past year number
 
Free-Form Entry
       
C21631
Swallowing post-SCI problem indicator
SwallowingPostSCIProbInd
Subject's response concerning problems with swallowing post-SCI.
Since your spinal cord injury, have you had any problems with your swallowing?
Yes;No;
Yes;No;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
1/6/2014
Aliases for variable name not defined
Clinical Assessment
Physical Examinations
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C06247
Cardiovascular event after spinal cord lesion type
CardioEvntAfterSpnlCrdLesnTyp
Events related to cardiovascular functions that may have occurred at any time after the spinal cord lesion.
Events related to cardiovascular function after spinal cord lesion
Cardiac pacemaker;Deep vein thrombosis;Myocardial infarction;None;Other,specify;Pulmonary embolism;Stroke;Unknown (any cardiovascular disorder);
Cardiac pacemaker;Deep vein thrombosis;Myocardial infarction;None;Other, specify;Pulmonary embolism;Stroke;Unknown (any cardiovascular disorder);
Alphanumeric
For each event related to cardiovascular function after spinal cord lesion record whether it was experienced by the participant.
These time-limited cardiovascular events with long-term sequelae should have their dates documented to be able to compute the time since injury and to identify the data collected in relation to various time points. If more than one episode has occured the last one has to be documented.
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
Supplemental
3.0
7/17/2013
Refer to SCI CDE Annotated Form
Clinical Assessment
Physical Examinations
Assessments and Examinations
Cardiovascular event after spinal cord lesion type
 
Multiple Pre-Defined Values Selected
       
C18794
Cardiovascular event after spinal cord lesion other text
CardioEvntAfterSpnlCrdLesnOTH
The free-text field related to 'Cardiovascular event after spinal cord lesion type' specifying other text. Events related to cardiovascular functions that may have occurred at any time after the spinal cord lesion.
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
Supplemental
3.0
7/17/2013
Aliases for variable name not defined
Clinical Assessment
Physical Examinations
Assessments and Examinations
 
4000
Free-Form Entry
       
C06249
Cardiovascular function after last three month type
CardioFnctnAfterLast3MnthTyp
Types of cardiovascular function that may have occurred after the spinal cord lesion (within three months).
Cardiovascular function after spinal cord lesion within the last three months
Autonomic dysreflexia;Cardiac conditions, specify;Dependent oedema;Hypertension;None;Orthostatic hypotension;Other,specify;Unknown (any cardiovascular disorder);
Autonomic dysreflexia;Cardiac conditions, specify;Dependent oedema;Hypertension;None;Orthostatic hypotension;Other, specify;Unknown (any cardiovascular disorder);
Alphanumeric
For each type of cardiovascular function after spinal cord lesion record whether it was experienced by the participant within the last three months.
Cardiac conditions: Subjective symptoms related to the heart that occur post-spinal cord lesion should be documented (e.g. abnormal heart rates/rhythm, angina, palpitation etc.).
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.
Dependent oedema: A clinically detectable increase in extracellular fluid volume localized in a dependent area, such as a limb, characterized by swelling or pitting.
Hypertension: (arterial blood pressure >140/90 mmHg). The diagnosis of hypertension in individual with SCI should be considered after careful monitoring and documentation of the level of arterial blood pressure and exclusion of possible elevation of BP due to episodes of AD.
Autonomic dysreflexia: A constellation of signs and/or symptoms in SCI above T5-6 spinal cord segments in response to noxious or non-noxious stimuli below the level of injury defined by an increase in systolic blood pressure (> 20mm Hg above baseline), and which may include one of the following symptoms: headache, flushing and sweating above the level of the lesion, vasoconstriction below the level of the lesion, and dysrhythmia. This syndrome may or may not be symptomatic and may occur at any time following SCI.
Consensus statement on the definition of orthostatic hypotension, pure autonomic failure, and multiple system atrophy. The Consensus Committee of the American Autonomic Society and the American Academy of Neurology. Neurol. 46, 1470 (1996). Gao,S.A., Ambring,A., Lambert,G. & Karlsson,A.K. Autonomic control of the heart and renal vascular bed during autonomic dysreflexia in high spinal cord injury. Clin. Auton. Res. 12, 457-464 (2002). Karlsson,A.K., Friberg,P., Lonnroth,P., Sullivan,L. & Elam,M. Regional sympathetic function in high spinal cord injury during mental stress and autonomic dysreflexia. Brain 121, 1711-1719 (1998). Kirshblum,S.C., House,J.G. & O'connor,K.C. Silent autonomic dysreflexia during a routine bowel program in persons with traumatic spinal cord injury: a preliminary study. Arch. Phys. Med. Rehabil. 83, 1774-1776 (2002). 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. Krassioukov,A. & Claydon,V.E. The clinical problems in cardiovascular control following spinal cord injury: an overview. Prog. Brain Res. 152, 223-229 (2006). Krassioukov,A.V., Furlan,J.C. & Fehlings,M.G. Autonomic dysreflexia in acute spinal cord injury: an under-recognized clinical entity. J. Neurotrauma 20, 707-716 (2003). Linsenmeyer,T.A., Campagnolo,D.I. & Chou,I.H. Silent autonomic dysreflexia during voiding in men with spinal cord injuries. J. Urol. 155, 519-522 (1996). Mathias,C.J. & Frankel,H.L. Autonomic Failure, A Textbook of Clinical Disorders of the Autonomic Nervous System. Bannister,R. & Mathias,C.J. (eds.), pp. 839-881 (Oxford Medical Publications,2002). Pickering,T.G. et al. Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Circula. 111, 697-716 (2005).
Adult;Pediatric
Supplemental
3.0
7/17/2013
Refer to SCI CDE Annotated Form
Clinical Assessment
Physical Examinations
Assessments and Examinations
Cardiovascular function within the last three months after spinal cord lesion type
 
Multiple Pre-Defined Values Selected
       
C18795
Cardiovascular function after last three month other text
CardioFuncAfterLast3MnthOTH
The free-text field related to 'Cardiovascular function after last three month type' specifying other text. Types of cardiovascular function that may have occurred after the spinal cord lesion (within three months).
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
Supplemental
3.0
7/17/2013
Aliases for variable name not defined
Clinical Assessment
Physical Examinations
Assessments and Examinations
 
4000
Free-Form Entry
       
C06014
Bladder empty need awareness indicator
BladEmpNeedAwreInd
Indicator of whether the participant is aware that he/she needs to empty his/her bladder.
Awareness of the need to empty the bladder
No;Yes;Not applicable;Not known;
No;Yes;Not applicable;Not known;
Alphanumeric
Choose one. Awareness of the need to empty the bladder indicates any kind of bladder sensation as defined by International Continence Society (Abrams et al. 2002), i.e. normal (the individual is aware of bladder filling and increasing sensation up to a strong desire to void), increased (the individual feels an early and persistent desire to void), reduced (the individual is aware of bladder filling but does not feel a definite desire to void) or non-specific bladder sensation (the individual reports no specific bladder sensation, but may perceive bladder filling as abdominal fullness, vegetative symptoms like sweating or spasticity). No awareness of the need to empty the bladder should be noted as "no". Absent bladder sensation according to the definition of bladder sensation by the International Continence Society (the individual reports no sensation of bladder filling or desire to void) (Abrams et al. 2002) is not exactly the same as filling sensation and desire to void can be absent while temperature sensation or electrosensation can be present. "Not applicable" is to be used when the individual with spinal cord lesion has for example an unclamped indwelling catheter or non-continent urinary diversion.

Response of "Not applicable" includes too young to determine.
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002:21;167-78. Biering-Sørensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International Lower Urinary Tract Function Basic Spinal Cord Injury Data Set. Spinal Cord 2008 May;46(5):325-30.
Adult;Pediatric
Supplemental
3.0
7/17/2013
AWARBLAD
Clinical Assessment
Physical Examinations
Assessments and Examinations
Bladder need to empty awareness indicator
 
Single Pre-Defined Value Selected
       
C06015
Bladder empty method main type
BladEmpMethdMainTyp
Main method of bladder emptying.
Bladder emptying
Bladder expression;Bladder reflex triggering;External compression bladder expression;Indwelling catheter;Intermittent catheterisation;Intermittent catheterisation by attendant;Intermittent self-catheterisation;Involuntary bladder reflex triggering;Non-continent urinary diversion/ostomy;Normal voiding;Other method, specify;Sacral anterior root stimulation;Straining bladder expression;Suprapubic;Suprapubic indwelling catheter;Transurethral indwelling catheter;Unknown;Voluntary bladder reflex triggering;
Comprises various manoeuvres aimed at increasing intravesical pressure in order to facilitate bladder emptying. The most commonly used manoeuvres are abdominal straining, Valsalva’s manoeuvre and Credé manoeuvre (Abrams et al. 2002).;Comprises various manoeuvres performed by the individual with spinal cord lesion or an attendant in order to elicit reflex detrusor contraction by exteroceptive stimuli. The most commonly used manoeuvres are suprapubic tapping, thigh scratching and anal/rectal manipulation (Abrams et al. 2002).;Includes Credé manoeuvre.;An indwelling catheter remains in the bladder, urinary reservoir or urinary conduit for a period of time longer than one emptying (Abrams et al. 2002).;Is defined as drainage or aspiration of the bladder or urinary reservoir/continent urinary diversion with subsequent removal of the catheter.;Is performed by an attendant (e.g. family member or personal aid);Is performed by the individual with spinal cord lesion himself/herself;Implies that there is no voluntary triggering of the voiding, but the individual with spinal cord lesion just let the urine run by itself when the reflex detrusor contraction occur by itself.;Non-continent urinary diversion/ostomy;Voluntary initiation of micturition without reflex stimulation or compression of the bladder. This does not presume entirely normal function (Levi and Ertzgaard 1998).;Other method, specify;Sacral anterior root stimulation;Includes abdominal straining, Valsalva’s manoeuvre.;Suprapubic;indicates, that the urine is drained through a catheter via the abdominal wall.;Indicates, that the urine is drained through a catheter placed in the urethra.;Unknown;Indicates that the bladder reflex is triggered by the spinal cord lesioned individual him/herself or by the attendant.;
Alphanumeric
For each method of bladder emptying, indicate whether this is a main or a supplementary method. Two main and more supplementary methods may be indicated (adopted from Levi and Ertzgaard 1998).
Normal voiding: Voluntary initiation of micturition without reflex stimulation or compression of the bladder. This does not presume entirely normal function (Levi and Ertzgaard 1998).
Bladder reflex triggering comprises various manoeuvres performed by the individual with spinal cord lesion or an attendant in order to elicit reflex detrusor contraction by exteroceptive stimuli. The most commonly used manoeuvres are
suprapubic tapping, thigh scratching and anal/rectal manipulation (Abrams et al. 2002).
Voluntary bladder reflex triggering indicates that the bladder reflex is triggered by the spinal cord lesioned individual him/herself or by the attendant.
Involuntary bladder reflex triggering imply that there is no voluntary triggering of the voiding, but the individual with spinal cord lesion just let the urine run by itself when the reflex detrusor contraction occur by itself.
Bladder expressioncomprises various manoeuvres aimed at increasing intravesical pressure in order to facilitate bladder emptying. The most commonly used manoeuvres are abdominal straining, Valsalva’s manoeuvre and Credé manoeuvre
(Abrams et al. 2002).
Straining includes abdominal straining, Valsalva’s manoeuvre.
External compression includes Credé manoeuvre.
Catheterisation is a technique for bladder emptying employing a catheter to drain the bladder or a urinary reservoir (Abrams et al. 2002).
Intermittent catheterisation is defined as drainage or aspiration of the bladder or urinary reservoir / continent urinary diversion with subsequent removal of the catheter.
The following types of intermittent catheterisationare defined by the International Continence Society (Abrams et al. 2002):
Intermittent self-catheterisation is performed by the individual with spinal cord lesion himself/herself
Intermittent catheterisation can also be performed by an attendant (e.g. Family member or personal aid)
Indwelling catheterisation:an indwelling catheter remains in the bladder, urinary reservoir or urinary conduit for a period of time longer than one emptying (Abrams et al. 2002).
Transurethral indwelling catheterisationindicates that the urine is drained trough a catheter placed in the urethra.
Suprapubic indwelling catheterisation indicates that the urine is drained trough a catheter via the abdominal wall.
Sacral Anterior Root Stimulator (SARS): Emptying the bladder by electrical stimulation of the anterior sacral nerve roots via implanted electrodes.
Non-continent urinary diversion/ostomy: This includes ureteroileocutaneostomy (Bricker conduit), ileovesicostomy, vesicostomy. If any other method is used for bladder emptying it is recommended to be written in a text-field, from which it will be possible to retrieve more detailed data when necessary. Because other methods of bladder emptying are generally rare, it is not practical to give an inclusive list of bladder emptying methods. Use of diapers etc. because of incontinence is not to be reported here,but under “Collecting appliances for urinary incontinence”.
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002:21;167-78. Biering-Sørensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International Lower Urinary Tract Function Basic Spinal Cord Injury Data Set. Spinal Cord 2008 May;46(5):325-30. Levi R, Ertzgaard P, The Swedish Spinal Cord Injury Council 1998. Quality indicators in spinal cord injury care: A Swedish collaboration project. Scand J Rehabil Med 1998;Suppl.38:1-80.
Adult;Pediatric
Supplemental
3.0
7/17/2013
EMBLADM
Clinical Assessment
Physical Examinations
Assessments and Examinations
Bladder emptying method main type
 
Single Pre-Defined Value Selected
       
C19467
Bladder empty method main other text
BladEmpMethdMainOTH
The free-text field to specify the main method of bladder emptying.
Other method, specify
  
Alphanumeric
No instructions available
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002:21;167-78. Biering-Sørensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International Lower Urinary Tract Function Basic Spinal Cord Injury Data Set. Spinal Cord 2008 May;46(5):325-30. Levi R, Ertzgaard P, The Swedish Spinal Cord Injury Council 1998. Quality indicators in spinal cord injury care: A Swedish collaboration project. Scand J Rehabil Med 1998;Suppl.38:1-80.
Adult;Pediatric
Supplemental
3.0
7/17/2013
Aliases for variable name not defined
Clinical Assessment
Physical Examinations
Assessments and Examinations
 
4000
Free-Form Entry
       
C06017
Bladder empty method supplementary type
BladEmpMethdSuppTyp
Supplementary type(s) of bladder emptying method(s)
Bladder emptying
Bladder expression;Bladder reflex triggering;External compression bladder expression;Indwelling catheter;Intermittent catheterisation;Intermittent catheterisation by attendant;Intermittent self-catheterisation;Involuntary bladder reflex triggering;Non-continent urinary diversion/ostomy;Normal voiding;Other method, specify;Sacral anterior root stimulation;Straining bladder expression;Suprapubic;Suprapubic indwelling catheter;Transurethral indwelling catheter;Unknown;Voluntary bladder reflex triggering;
Comprises various manoeuvres aimed at increasing intravesical pressure in order to facilitate bladder emptying. The most commonly used manoeuvres are abdominal straining, Valsalva’s manoeuvre and Credé manoeuvre (Abrams et al. 2002).;Comprises various manoeuvres performed by the individual with spinal cord lesion or an attendant in order to elicit reflex detrusor contraction by exteroceptive stimuli. The most commonly used manoeuvres are suprapubic tapping, thigh scratching and anal/rectal manipulation (Abrams et al. 2002).;Includes Credé manoeuvre.;An indwelling catheter remains in the bladder, urinary reservoir or urinary conduit for a period of time longer than one emptying (Abrams et al. 2002).;Is defined as drainage or aspiration of the bladder or urinary reservoir/continent urinary diversion with subsequent removal of the catheter.;Is performed by an attendant (e.g. family member or personal aid);Is performed by the individual with spinal cord lesion himself/herself;Implies that there is no voluntary triggering of the voiding, but the individual with spinal cord lesion just let the urine run by itself when the reflex detrusor contraction occur by itself.;Non-continent urinary diversion/ostomy;Voluntary initiation of micturition without reflex stimulation or compression of the bladder. This does not presume entirely normal function (Levi and Ertzgaard 1998).;Other method, specify;Sacral anterior root stimulation;Includes abdominal straining, Valsalva’s manoeuvre.;Suprapubic;indicates, that the urine is drained through a catheter via the abdominal wall.;Indicates, that the urine is drained through a catheter placed in the urethra.;Unknown;Indicates that the bladder reflex is triggered by the spinal cord lesioned individual him/herself or by the attendant.;
Alphanumeric
For each method of bladder emptying, indicate whether this is a main or a supplementary method. Two main and more supplementary methods may be indicated (adopted from Levi and Ertzgaard 1998).
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The Standardisation of Terminology of Lower Urinary Tract Function: Report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002:21;167-78. Biering-Sørensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International Lower Urinary Tract Function Basic Spinal Cord Injury Data Set. Spinal Cord 2008 May;46(5):325-30. Levi R, Ertzgaard P, The Swedish Spinal Cord Injury Council 1998. Quality indicators in spinal cord injury care: A Swedish collaboration project. Scand J Rehabil Med 1998;Suppl.38:1-80.
Adult;Pediatric
Supplemental
3.0
7/17/2013
Refer to SCI CDE Annotated Form
Clinical Assessment
Physical Examinations
Assessments and Examinations
Bladder emptying method supplementary type
 
Single Pre-Defined Value Selected
       
C19476
Bladder empty method supplementary other text
BladEmpMethdSupplOTH
The free-text field to specify the supplementary method of bladder emptying.
Other method, specify
  
Alphanumeric
No instructions available
Biering-Sørensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International Lower Urinary Tract Function Basic Spinal Cord Injury Data Set. Spinal Cord 2008 May;46(5):325-30.
Adult;Pediatric
Supplemental
3.0
7/17/2013
Aliases for variable name not defined
Clinical Assessment
Physical Examinations
Assessments and Examinations
 
4000
Free-Form Entry
       
12-19-2018
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