CDE Detailed Report

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

Displaying 1 - 26 of 26
CDE ID CDE Name Variable Name Definition Short Description Question Text Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C06451 Neuromuscular scoliosis assessment method type NeromusclrSclsisAssmntMethdTyp Type of method(s) used to determine the presence of neuromuscular scoliosis. Type of method(s) used to determine the presence of neuromuscular scoliosis. If scoliosis present, method of assessment Observation in sitting;Observation in standing;Plain radiographs in sitting;Plain radiographs in standing Observation in sitting;Observation in standing;Plain radiographs in sitting;Plain radiographs in standing Alphanumeric

Check all that apply

O'Brien MF. (2005). Spinal Deformity Study Group Radiographic Measurement Manual Medtronic Sofamor Danek USA, Inc. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets

Multiple Pre-Defined Values Selected

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.).

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets

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C06452 Neuromuscular scoliosis surgery treat indicator NeuromusclrSclsisSurgTrtInd Indicator of whether the scoliosis has been surgical treated. Indicator of whether the scoliosis has been surgical treated. Surgically treated? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one

Brown JC, Swank SM, Matta J, Barras DM. Late spinal deformity in quadriplegic children. J Pediatric Orthopedics, 1984;4:456-461. Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06432 Neuro-Musculoskeletal history before spinal cord lesion type NeurmsckltlHstBfrSpnlCrdLsnTyp Type of neuro-musculoskeletal history before spinal cord lesion Type of neuro-musculoskeletal history before spinal cord lesion Pre-existing congenital deformities of the spine and spinal cord;Pre-existing degenerative spine disorders;Pre-existing systemic neuro-degenerative disorders Pre-existing congenital deformities of the spine and spinal cord;Pre-existing degenerative spine disorders;Pre-existing systemic neuro-degenerative disorders Alphanumeric No references available Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets

Multiple Pre-Defined Values Selected

C06454 Musculoskeletal other problem text MusclskltlOthrProbTxt Text describing the presence of any other musculoskeletal problems not described elsewhere. Text describing the presence of any other musculoskeletal problems not described elsewhere. Other musculoskeletal problems; specify Alphanumeric

Specify any other type of musculoskeletal problem not captured in the other variables. This could among other issues include gibbus formation in relation to Pott's paraplegia.

Benzagmout M, Boujraf S, Chakour K, Chaoui Mel F. Pott's disease in children. Surg Neurol Int. 2011 Jan 11;2:1. Moon MS, Moon JL, Moon YW, Kim SS, Kim SS, Sun DH, Choi WT. Pott's paraplegia in patients with severely deformed dorsal or dorsolumbar spines: treatment and prognosis. Spinal Cord. 2003 Mar;41(3):164-71. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets 255

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C06435 Neuro-Musculoskeletal condition type NeuroMuscskltlCondTyp Type of neuro-musculoskeletal condition experienced or diagnosed Type of neuro-musculoskeletal condition experienced or diagnosed Fractures, heterotopic ossifications, contractures, or degenerative changes/overuse Fracture;Heterotopic ossification;Contracture;Degenerative change/overuse Fracture;Heterotopic ossification;Contracture;Degenerative change/overuse Alphanumeric

Identifies whether the anatomic site and laterality type describes the fracture, heterotopic ossification, contracture, or degenerative change/overuse

No references available Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06455 Musculoskeletal challenge interfere activity scale MsclskltlChllngIntrfrActvtyScl Scale for how the musculoskeletal challenges interfere with the participant's daily activities of daily livings including transfers, walking, dressing, and showers. Scale for how the musculoskeletal challenges interfere with the participant's daily activities of daily livings including transfers, walking, dressing, and showers. Do any of the above musculoskeletal challenges interfere with your activities of daily living (transfers, walking, dressing, showers, etc.)? Yes, a little;Yes, a lot;No, not at all Yes, a little;Yes, a lot;No, not at all Alphanumeric

This element requires the assessor to directly ask the individual with spinal cord lesion the following question "Does any of the musculoskeletal challenges above interfere with your activities of daily living (transfers, walking, dressing, showers, etc.)?"

Lechner HE, Frotzler A, Eser P. Relationship between self- and clinically rated spasticity in spinal cord injury. Arch Phys Med Rehabil. 2006 Jan;87(1):15-9. Vogel LC, Betz RR, Mulcahey MJ: Pediatric Spinal Cord Disorders in Children and Adolescents. In: Lin V, ed. Spinal Cord Medicine Textbook. Demos, New York, New York, 2003, 851-884. Lubicky J, Betz R. Spinal deformity in children and adolescents with spinal cord injury. In: Betz RR & Mulcahey MJ: (Eds) The Child with Spinal Cord injury. American Academy of Orthopedic Surgeons: Rosemont, IL, Chapter 32, pp363-370, 1996. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06436 Neuro-Musculoskeletal condition anatomic site NeuroMuscskltlCondAntmicSite Anatomic site of the neuro-musculoskeletal condition experienced or diagnosed Anatomic site of the neuro-musculoskeletal condition experienced or diagnosed Location Neck/Cervical spine;Shoulder/Humerus;Elbow;Forearm;Wrist;Hand;Upper back/Thoracic spine;Lower back/Lumbar spine;Pelvis;Hip/Femur;Knee;Tibia/Fibula;Ankle;Foot Neck/Cervical spine;Shoulder/Humerus;Elbow;Forearm;Wrist;Hand;Upper back/Thoracic spine;Lower back/Lumbar spine;Pelvis;Hip/Femur;Knee;Tibia/Fibula;Ankle;Foot Alphanumeric

Choose one for each neuro-musculoskeletal condition (fracture, heterotopic ossification, contracture, or degenerative change/overuse)

Fergusson D, Hutton B and Drodge A. The epidemiology of major joint contractures: A systematic review of the literature. Clinical Orthopaedics and Related Research. 2006;14:22-29. Apple, D, Cody, R, Allen, A. Overuse Syndrome of the Upper Limb in People With Spinal Cord Injury. In: Apple, DF, Editor, Physical Fitness: A guide for individuals with spinal cord injury. Journal of Rehabilitation Research and Development, Chapter 5, 1996 (Clinical Supplement): 97-108 Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C18174 Pre-exist diagnosis location text PrexstDiagnsisLoctnTxt Text describing the diagnosis and location of the pre-existing neuro-musculoskeletal history of either the spin and spinal cord, degenerative spine disorders, or systemic neuro-degenerative disorders. Text describing the diagnosis and location of the pre-existing neuro-musculoskeletal history of either the spin and spinal cord, degenerative spine disorders, or systemic neuro-degenerative disorders. If yes, specify Diagnosis and Location Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets 255

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C06439 Fracture date FractrDate Date (and time, if applicable and known) the fracture occurred at each site Date (and time, if applicable and known) the fracture occurred at each site Date of fracture 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 Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets

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C18798 Heterotopic ossification detection method other text HetrotpcOssfctnDetctnMethdOTH The free-text field related to 'Heterotopic ossification detection method type' specifying other text. Type of method used to document the heterotopic ossification The free-text field related to 'Heterotopic ossification detection method type' specifying other text. Type of method used to document the heterotopic ossification Other, specify Alphanumeric

Indicate the method used to confirm the presence of heterotopic ossification

No references available Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets 4000

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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 Alphanumeric

Code each of the pre-existing neuro-musculoskeletal conditions and/or surgeries using SNOMED CT

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 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets 255

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C06440 Fragility fracture indicator FragltyFractrInd Indicator of whether the fracture is a fragility fracture. Fragility fractures result from low force injuries insufficient to fracture normal bone Indicator of whether the fracture is a fragility fracture. Fragility fractures result from low force injuries insufficient to fracture normal bone Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one

Jiang SD, Dai LY, Jiang LS. Osteoporosis after spinal cord injury. Osteoporos Int 2006; 17: 180-192. Craven BC, Robertson LA, McGillivray CF, Adachi JD. Detection and Treatment of Sublesional Osteoporosis Among Patients with Chronic Spinal Cord Injury: Proposed Paradigms. Topics in Spinal Cord Rehabilitation 2009; 14(4):1-22. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C19202 Pre spinal cord lesion neuro-musculoskeletal history type PreSpnlCrdLsnNroMscSkelHistTyp Type of neuro-musculoskeletal history prior to spinal cord lesion Type of neuro-musculoskeletal history prior to spinal cord lesion Neuro-musculoskeletal history before spinal cord lesion None;Pre-existing congenital deformities of the spine and spinal cord;Pre-existing degenerative spine disorders;Pre-existing systemic neuro-degenerative disorders None;Pre-existing congenital deformities of the spine and spinal cord;Pre-existing degenerative spine disorders;Pre-existing systemic neuro-degenerative disorders Alphanumeric Adult;Pediatric Supplemental 1.00 2014-06-03 11:51:17.0 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C00317 Medical history condition start date and time MedclHistCondStrtDateTime Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history Date or Date & Time

Document the date of the surgery related to the pre-existing neuro-musculoskeletal condition. 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 3.00 2013-07-25 08:54:08.2 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets

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2543596
C06447 Spasticity spasm indicator SpasctySpsmInd Indicator of the presence of spasticity/spasms Indicator of the presence of spasticity/spasms Presence of spasticity/spasms Yes;No;Unknown Yes;No;Unknown Alphanumeric

The presence of spasticity / spasms in the upper and lower extremities is captured using the modified Ashworth scale (MAS), i.e. greater than 1 on the MAS, or observation of spasms.

Bohannon RW, Smith MB. Interrater reliability of a Modified Ashworth Scale of muscle spasticity. Physical Therapy. 1987:67:206-7. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C19203 Pre-existing congenital deformity specify diagnosis name CongentlDeformSpecifyDiagName Specifies name of pre-existing congenital deformity of the spine and spinal cord Specifies name of pre-existing congenital deformity of the spine and spinal cord If yes, specify diagnosis and location Alphanumeric Adult;Pediatric Supplemental 1.00 2014-06-03 14:52:14.0 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets 4000

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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 If previous surgery due to this, description Alphanumeric

Document the specific diagnosis for each pre-existing neuro-musculoskeletal condition and document the location/anatomic site if not obvious. Previous surgeries due to any of the conditions should also be documented with this element. Record each condition or surgery on separate lines.

No references available Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets 4000

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2003874
C06448 Spasticity spasm treat last four week indicator SpasctySpsmTrtLst4WkInd Indicator of whether the person with SCI has received any kind of treatment for spasticity/spasms within the last four weeks. Indicator of whether the person with SCI has received any kind of treatment for spasticity/spasms within the last four weeks. Treatment for spasticity/spasms within the last four weeks? Yes;No;Unknown Yes;No;Unknown Alphanumeric

YES should be indicated if any kind of treatment has been used for spasticity over the last four weeks regardless of whether it was or was not prescribed.

No references available Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C19204 Pre-existing congenital deformity specify anatomic site CongentlDeformSpcfyAntmicSite Anatomic site of pre-existing congenital deformity of spine and spinal cord Anatomic site of pre-existing congenital deformity of spine and spinal cord If yes, specify diagnosis and location Alphanumeric Adult;Pediatric Supplemental 1.00 2014-06-03 14:57:24.0 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets 4000

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C02411 Laterality type LatTyp Laterality type relative to the anatomic site of the body examined or affected Laterality type relative to the anatomic site of the body examined or affected Right/Left Bilateral;Left;Right;Unknown;Midline Bilateral;Left;Right;Unknown;Midline Alphanumeric

Document the location (anatomic site and side) of each fracture

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06449 Heterotopic ossification detection method type HetrotpcOssfctnDetctnMethdTyp Type of method used to document the heterotopic ossification Type of method used to document the heterotopic ossification Method used to document heterotopic ossification, if present X-ray;CT-scan;Triple phase bone scan;Other, specify X-ray;CT-scan;Triple phase bone scan;Other method Alphanumeric

Indicate the method used to confirm the presence of heterotopic ossification

No references available Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets

Multiple Pre-Defined Values 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.

No references available Adult;Pediatric Supplemental 1.00 2014-06-05 13:10:49.0 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets 255

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C05106 Surgical or therapeutic procedure start date and time SurgTherapuProcStartDateTime Date (and time, if applicable and known) on which the surgical or therapeutic procedure started Date (and time, if applicable and known) on which the surgical or therapeutic procedure started Date of surgery 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.).

Brown JC, Swank SM, Matta J, Barras DM. Late spinal deformity in quadriplegic children. J Pediatric Orthopedics, 1984;4:456-461. Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets

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C06450 Neuromuscular scoliosis indicator NeuromusclrSclsisInd Indicator of any appreciable observable lateral deviation in the normally straight vertical line of the spine due to the sequelae of spinal cord injury (SCI) Indicator of any appreciable observable lateral deviation in the normally straight vertical line of the spine due to the sequelae of spinal cord injury (SCI) Scoliosis Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one

Brown JC, Swank SM, Matta J, Barras DM. Late spinal deformity in quadriplegic children. J Pediatric Orthopedics, 1984;4:456-461. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value 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.

No references available Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Musculoskeletal Basic Data Set The International SCI Data Sets The International SCI Data Sets 255

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CSV