CDE Detailed Report

Disease: Spinal Cord Injury
Sub-Domain: The International SCI Data Sets
CRF: International SCI Spinal Column Injury Basic Data Set

Displaying 1 - 10 of 10
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (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
C05452 Spinal injury anatomic site SpnlInjAntmicSit Anatomic site(s) of the spine injury represented as level(s) of the spinal-injured vertebrae. 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;L1;L2;L3;L4;L5;S1;S2;S3;S4-5;T1;T2;T3;T4;T5;T6;T7;T8;T9;T10;T11;T12 C0;C1;C2;C3;C4;C5;C6;C7;L1;L2;L3;L4;L5;S1;S2;S3;S4-5;T1;T2;T3;T4;T5;T6;T7;T8;T9;T10;T11;T12 Alphanumeric

This element documents the spinal column level (or vertebral level) and not the neurological level. This is to be filled in for each level of injury, starting with the most cephalic injury. In the case of multiple spinal injuries, a separate entry will be completed for each spinal column injury level. The code X99 should be used only if the level is completely 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 Jun 5. [Epub ahead of print] Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 International SCI Spinal Column Injury Basic Data Set The International SCI Data Sets The International SCI Data Sets

Multiple Pre-Defined Values Selected

C06000 Site identifier number SiteIDNum Unique identification number given to the study site to distinguish the location where data is recorded. Unique identification number given to the study site to distinguish the location where data is recorded. Site Alphanumeric

The site identifiers or IDs should be assigned by the study.

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 Jun 5. [Epub ahead of print] Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Spinal Column Injury Basic Data Set The International SCI Data Sets The International SCI Data Sets 255

Free-Form Entry

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. Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed. Date 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.).

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 Jun 5. [Epub ahead of print] Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 International SCI Spinal Column Injury Basic Data Set The International SCI Data Sets The International SCI Data Sets

Free-Form Entry

C06426 Spinal cord injury type SpnlCrdInjTyp The mechanism of spinal cord injury The mechanism of spinal cord injury Penetrating/blunt injury Blunt;Penetrating;Unknown Blunt;Penetrating;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 Jun 5. [Epub ahead of print] Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Spinal Column Injury Basic Data Set The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

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. 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 No;Yes;Unknown No;Yes;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 Jun 5. [Epub ahead of print] Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Spinal Column Injury Basic Data Set The International SCI Data Sets The International SCI Data Sets

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. 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 Jun 5. [Epub ahead of print] Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Spinal Column Injury Basic Data Set The International SCI Data Sets The International SCI Data Sets

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. 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

Record the injury number if 2 or more injuries were experienced. Check against single/multiple variable to ensure only one record exists if Single was checked, and 2 or more records exist if Multiple was checked.

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 Jun 5. [Epub ahead of print] Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Spinal Column Injury Basic Data Set The International SCI Data Sets The International SCI Data Sets

Free-Form Entry

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. Question to find out if the client has a disc/posterior ligamentous complex injury. Disc/posterior ligamentous complex injury No;Yes;Unknown No;Yes;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.

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 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 Jun 5. [Epub ahead of print] 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). Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Spinal Column Injury Basic Data Set The International SCI Data Sets The International SCI Data Sets

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). Question to find out if the client has a traumatic translation. Traumatic translation No;Yes;Unknown No;Yes;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.

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 Jun 5. [Epub ahead of print] Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Spinal Column Injury Basic Data Set The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C19247 Subject ID SubIDNam Subject identification ID Subject identification ID Subject Alphanumeric

The participant or subject identifiers or IDs should be assigned by the study.

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 Jun 5. [Epub ahead of print] Adult;Pediatric Supplemental 1.00 2014-06-05 13:10:49.0 International SCI Spinal Column Injury Basic Data Set The International SCI Data Sets The International SCI Data Sets 255

Free-Form Entry

CSV